Clinical trial • Phase II/III • Neurology

JX10 for Acute ischemic stroke

Phase II/III trial of JX10 for Acute ischemic stroke.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Acute ischemic stroke
Trial Stage
Phase II/III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
03-03-2025
First CTIS Authorization Date
23-06-2025

Trial design

Randomised, placebo (jx10 placebo drug product is prepared as a sterile, lyophilized white to light yellow cake or powder for infusion).-controlled Phase II/III trial in Hungary, Italy, Belgium and others.

Randomised
Yes
Comparator
Placebo (Jx10 placebo drug product is prepared as a sterile, lyophilized white to light yellow cake or powder for infusion).
Target Sample Size
671
Trial Duration For Participant
90

Eligibility

Recruits 671 Vulnerable populations are selected (isVulnerablePopulationSelected = true). Written informed consent may be provided by the patient, the patient’s legally authorised representative, or an independent physician where local regulation allows. Consent must comply with local and national regulations or local ethics committee guidelines. Participants are adults (≥18 years); no paediatric assent procedures are specified..

Pregnancy Exclusion
All women of childbearing potential and all men must practice contraception as described in Section 8.3.5. For women of childbearing potential, a negative pregnancy test at screening is required. All women of childbearing potential must practice effective contraception for at least 30 days after their last dose of study treatment. All men must practice effective contraception during the study and for 90 days after their last dose of study treatment. In addition, participants should not donate sperm or eggs during the study and for at least 90 days after their dose of study treatment.
Vulnerable Population
Vulnerable populations are selected (isVulnerablePopulationSelected = true). Written informed consent may be provided by the patient, the patient’s legally authorised representative, or an independent physician where local regulation allows. Consent must comply with local and national regulations or local ethics committee guidelines. Participants are adults (≥18 years); no paediatric assent procedures are specified.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 and ≤ 90 years old (Age > 85 must be mRS 0 at baseline (premorbid) to be eligible).\n- Written informed consent by patient, his her legally authorized representative, or independent physician where local regulation allows (in accordance with all local and national regulations or according to the local ethics committee's guidelines or by another process compliant with applicable national laws and regulations and ethics committee requirements).\n- Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA), demonstrated by: a. Computer Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) with high grade stenosis or occlusion of an eligible artery, or b. Computer Tomography or Magnetic Resonance Perfusion (CTP MRP) with focal deficit in an eligible artery, or c. Non-contrast Computer Tomography (NCCT) with hyperdense artery sign in an eligible artery or Magnetic Resonance Imaging (MRI) with susceptibility vessel sign (defined as a hypointense signal exceeding the diameter of the contralateral artery at the thrombus site) in an eligible artery.\n- Radiographic evidence of salvageable tissue* is present based on: a. A mismatch ratio (perfusion lesion (Tmax > 6 seconds) volume core estimate) > 1.2, b. Estimated core infarct volume < 70 mL, and c. Total mismatch volume ≥ 10 mL on CTP or magnetic resonance (MR) perfusion weighted imaging (PWI) MRI diffusion imaging. The perfusion criteria apply to all participants, including those who present within 4.5 to 6 hours of LKW, if perfusion imaging is obtained. Perfusion is mandatory for patients presenting beyond 6 hours, optional for patients < 6 hours. *The quantitative assessment of penumbra may include alternative methods (e.g., if the software uses different parameters in place of Tmax).\n- Presentation with intended study treatment within 4.5 to 6 hours of Last Know Well (LKW) in the absence of radiographic assessment of perfusion or within 4.5 to 24 hours of LKW with radiographic evidence of penumbra meeting criterion\n- Pre-treatment score of NIHSS ≥ 5.\n- Functionally independent prior to stroke onset as evidenced by premorbid mRS < 2 (< 1 if age 86-90).\n- All women of childbearing potential and all men must practice contraception as described in Section 8.3.5. For women of childbearing potential, a negative pregnancy test at screening is required. All women of childbearing potential must practice effective contraception for at least 30 days after their last dose of study treatment. All men must practice effective contraception during the study and for 90 days after their last dose of study treatment. In addition, participants should not donate sperm or eggs during the study and for at least 90 days after their dose of study treatment."}

Exclusion criteria

  • {"criterion_text":"- Radiographic findings pre-randomization of any of the following: a. Large core infarction, evidenced by a core infarct volume > 70 mL, assessed on DWI or CTP; or extensive early ischemic change (hypodensity) on non-contrast CT estimated to be > 1 3 MCA territory, or significant hypodensity outside the Tmax > 6 seconds perfusion lesion that invalidates mismatch criteria, or b. Occlusion in more than 1 vascular territory confirmed on CTA MRA, or c. Significant mass effect or clinically significant cerebral edema per Investigator’s judgement, or d. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation, or e. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.\n- Major trauma, surgery, or invasive procedures: a. Severe head trauma within 3 months of screening or acute head trauma. b. Major trauma not involving the head within 14 days of screening. c. Major surgery with 14 days of screening. d. Intracranial or intraspinal surgery within 90 days of screening. e. Dural puncture (e.g., lumbar puncture) or arterial puncture of a noncompressible blood vessel within 7 days of screening.\n- Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.\n- Pre-treatment blood glucose > 400 mgdL (22.20 mmolL) or Pre-treatment blood glucose < 50 mgdL (2.78 mmolL) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.\n- Known hereditary or acquired abnormality of UGT1A1 metabolism or deficiency such as Gilbert's syndrome (hereditary liver condition with elevated bilirubin), Crigler-Najjar syndrome (UGT1A1 gene defect associated with congenital non-hemolytic jaundice).\n- Prolonged QT with QTc of > 450 ms for males and > 460 ms for females\n- Life expectancy less than 6 months due to comorbid condition.\n- Prior thrombolytic administration within 90 days of screening or planned thrombolytic administration for the AIS. (Co-administration with any other thrombolytic agent(s) within 48 hours is prohibited).\n- Known or suspected use of any oral anticoagulant therapy, including but not limited to vitamin K antagonists, thrombin inhibitors, or factor Xa inhibitors, within 48 hours of screening unless blood testing confirms absence of drug substance in the system.\n- Use of dual anti-platelet therapy, IV aspirin, or glycoprotein IIb/IIIa inhibitors within 24 hours of screening. Pre-screening use of oral antiplatelet monotherapy with aspirin at doses less than or equal to 325 mg daily OR clopidogrel 75 mg daily is permitted.\n- Use of heparin or low molecular weight heparin at a therapeutic dose, excluding prescreening prophylactic dose low molecular weight heparin with a normal aPTT.\n- Non-ischemic or non-thrombotic etiology of current stroke symptoms such as suspected cerebral vasospasm, infectious source (e.g., bacterial endocarditis, septic shock), complications from acute drug abuse (e.g., cocaine intoxication).\n- Use of nephrotoxic medications or agents within 7 days of screening that would (in the investigator’s opinion) pose significant risk of acute kidney injury (e.g. aminoglycosides, cyclosporins, lactams, amphotericin B, cisplatin, indomethacin, etc.).\n- Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator’s judgement) considered to be of significant risk for major bleeding; (this may include but not limited to any history of intracranial hemorrhage or vascular aneurysm of the large arteries of major intraspinal or intracerebral abnormalities).\n- Cerebral infarction within 90 days of screening.\n- Arterial dissection involving any intracranial artery or the aortic arch. Confirmed acute coronary syndrome within 90 days of screening.\n- Severe hepatic impairment as defined by decompensated liver disease (e.g., Child-Pugh Class C) or clinically significant hepatic condition associated with coagulopathy or bleeding risk.\n- Medical history of chronic renal failure, any condition requiring dialysis or renal replacement therapy or evidence of acute kidney injury at the time of screening, an estimated glomerular filtration rate < 60 mLmin1.73m2.\n- Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.\n- Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count < 100,000 microliter, international normalized ratio > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy: Proportion of participants with no or minimal symptoms at 90 days.","definition_or_measurement_approach":"Measured as proportion of participants with Modified Rankin Scale (mRS) score 0–1 at 90 days (no or minimal symptoms)."}
  • {"endpoint_text":"- Safety: Incidence of symptomatic intracranial hemorrhage, defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and or intraventricular hemorrhage within 36 hours post-randomization, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline (the closest collection before administration of the study treatment), or from the lowest NIHSS value between baseline and 24 hours, or leading to death.","definition_or_measurement_approach":"Symptomatic intracranial hemorrhage defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage within 36 hours post-randomization combined with neurological deterioration of ≥4 points on NIHSS from baseline or from the lowest NIHSS between baseline and 24 hours, or resulting in death."}

Recruitment

Planned Sample Size
671
Recruitment Window Months
51
Consent Approach
Written informed consent by the patient, the patient's legally authorised representative, or an independent physician where local regulation allows ("Written informed consent by patient, his her legally authorized representative, or independent physician where local regulation allows (in accordance with all local and national regulations or according to the local ethics committee's guidelines or by another process compliant with applicable national laws and regulations and ethics committee requirements)."). Participants are adults (≥18) so no paediatric assent. Subject information and consent materials are available in multiple country-specific language versions (documents listed include English, French, Spanish, Italian, German, Hungarian, Polish, Lithuanian, Bulgarian, Portuguese, Greek, Finnish, Dutch, Latvian, Russian among others) as provided in the submission materials.

Geography

Total Number Of Sites
66
Total Number Of Participants
671

Hungary

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
32
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Semmelweis University
Department Name
Neurológiai Klinika
Contact Person Name
Bence Gunda
Contact Person Email
bence.gunda@gmail.com
Site Name
Semmelweis University
Department Name
Idegsebészeti és Neurointerveciós Klinika
Contact Person Name
Sándor Nardai
Contact Person Email
snardai@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
20-05-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
45
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Alessandro Manzoni Hospital
Department Name
Dipartimento Area Neuroscienze
Contact Person Name
Andrea Salmaggi
Contact Person Email
a.salmaggi@asst-lecco.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Neurologia - UOS Neurologia D'Urgenza
Contact Person Name
Giovanni Frisullo
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
Stroke Unit - DEA padiglione 43
Contact Person Name
Anna Maria Cavallini
Contact Person Email
anna.cavallini@mondino.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
OUC Neurologia A
Contact Person Name
Manuel Cappellari
Site Name
Humanitas Mirasole S.p.A.
Department Name
Neurologia d'Urgenza e Stroke Unit
Contact Person Name
Simona Marcheselli
Site Name
San Camillo Forlanini Hospital
Department Name
UOSD Stroke Unit
Contact Person Name
Sabrina Anticoli

Belgium

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
11
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Neurology
Contact Person Name
Dimitri Hemelsoet
Contact Person Email
dimitri.hemelsoet@uzgent.be
Site Name
Jessa Ziekenhuis
Department Name
Neurology
Contact Person Name
Nina de Klippel
Contact Person Email
nina.deklippel@jessazh.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Neurology
Contact Person Name
Sofie De Blauwe
Contact Person Email
Sofie.Deblauwe@azsintjan.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Neorology
Contact Person Name
Geraldine Dasnoy-Sumell
Contact Person Email
g.dasnoy@chuliege.be

Poland

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
39
Number Of Sites
5
Number Of Participants
29

Sites

Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Neurologii
Contact Person Name
Anetta Lasek-Bal
Contact Person Email
alasek@gcm.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Uniwersyteckie Centrum Neurologii i Neurochirurgii, Oddział Kliniczny Neurologii
Contact Person Name
Marta Nowakowska-Kotas
Contact Person Email
nowakowska-kotas@usk.wroc.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Neurologi
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddział Kliniczny Neurologii
Contact Person Name
Jacek Rożniecki
Contact Person Email
jacek.rozniecki@umed.lodz.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Contact Person Name
Bożena Adamkiewicz
Contact Person Email
neurologia@kopernik.lodz.pl

Greece

Earliest CTIS Part Ii Submission Date
10-07-2025
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
41
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
Second Department of Neurology, National and Kapodistrian University of Athens, PC 124 62
Contact Person Name
Georgios Tsivgoulis
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
2nd Department of Neurology, Aristotle University of Thessaloniki
Contact Person Name
Theodoros Karapanayiotides
Contact Person Email
tkarapanayiotides@yahoo.gr
Site Name
General University Hospital Of Patras
Department Name
Department of Neurology
Contact Person Name
John Ellul
Contact Person Email
ellul@upatras.gr
Site Name
Henry Dunant Hospital Center
Department Name
1st Neurology Clinic
Contact Person Name
Dimitra Papadimitriou
Contact Person Email
d.papadimitriou@dunant.gr

Lithuania

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
22
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Neurology
Contact Person Name
Vaidas Matijosaitis
Site Name
Respublikine Vilniaus universitetine ligonine VšĮ
Department Name
Neurology
Contact Person Name
Aleksandras Vilionskis
Contact Person Email
aleksandras.vilionskis@rvul.lt
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Neurology
Contact Person Name
Dalius Jatuzis
Contact Person Email
dalius.jatuzis@santa.lt

Bulgaria

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
22
Number Of Sites
7
Number Of Participants
43

Sites

Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Department of General Neurology at the Clinic of Nervous Diseases
Contact Person Name
Penka Atanasova
Contact Person Email
prof.penka.atanasova@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Clinic of Nervous Diseases
Contact Person Name
Ivan Dimitrov
Contact Person Email
i.dimitrov.bs@heartandbrain.bg
Site Name
Multiprofile Hospital For Active Treatment Blagoevgrad AD
Department Name
Department of Neurology Diseases
Contact Person Name
Spaska Georgieva – Zhostova
Contact Person Email
Space_georgieva@abv.bg
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic for Intensive Treatment of Nervous Diseases
Contact Person Name
Evguenia Roustcheva
Contact Person Email
Dr.evgenia.vasileva@gmail.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Clinic of Neurology Diseases
Contact Person Name
Plamen Bozhinov
Contact Person Email
psbozhinov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of Neurology Diseases
Contact Person Name
Mariya Dimitrova
Contact Person Email
Dr.m.i.dimitrova@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
60
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Stroke Unit
Contact Person Name
André Florêncio
Contact Person Email
andre_florencio@hotmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Neurology
Contact Person Name
Carla Ferreira
Contact Person Email
carla.m.c.ferreira@gmail.com
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Neurology
Contact Person Name
Vitor Cruz
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Neurology
Contact Person Name
Liliana Pereira
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Neurology
Contact Person Name
Sofia Rodrigues
Contact Person Email
anasofia.grodrigues@gmail.com

Latvia

Earliest CTIS Part Ii Submission Date
10-09-2025
Latest Decision Or Authorization Date
12-10-2025
Processing Time Days
32
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Riga East Clinical University Hospital
Department Name
Neurology and Neurosurgery
Contact Person Name
Guntis Karelis
Contact Person Email
guntis.karelis@aslimnica.lv
Site Name
Pauls Stradins Clinical University Hospital
Department Name
Neurology
Contact Person Name
Kristaps Jurjāns
Contact Person Email
kristaps.jurjans@gmail.com
Site Name
Daugavpils regionala slimnica SIA
Department Name
Neurology
Contact Person Name
Natalja Pontaga
Contact Person Email
natalja.pontaga@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
108
Number Of Sites
14
Number Of Participants
19

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Carlos Alberto Molina Cateriano
Contact Person Email
cmolina@vhebron.net
Site Name
Hospital Universitario De Cruces
Department Name
Neurology
Contact Person Name
Maria del Mar Freijo Guerrero
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Soledad Pérez Sánchez
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Rafael Bustamante
Contact Person Email
r.bustamante.eecc@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Gerardo Fortea-Cabo
Contact Person Email
forte_ger@gva.es
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Neurology
Contact Person Name
Juan Francisco Arenillas Lara
Contact Person Email
juanfarenillas@gmail.com
Site Name
Hospital General Universitario De Albacete
Department Name
Neurology
Contact Person Name
Tomas Segura Martin
Contact Person Email
tseguram@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neurology
Contact Person Name
Jaime Masjuan Vallejo
Contact Person Email
jaime.masjuan@salud.madrid.org
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Neurology
Contact Person Name
Yolanda Silva Blas
Contact Person Email
ysilva.girona.ics@gencat.cat
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Neurology
Contact Person Name
Maria del Mar Castellanos Rodrigo
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurology
Contact Person Name
Ana María Iglesias Mohedano
Contact Person Email
a.iglesiasmohedano@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Neurology
Contact Person Name
Blanca Fuentes Gimeno
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Neurology
Contact Person Name
Joaquín Carneado-Ruiz
Contact Person Email
jcarnead@hotmail.com
Site Name
Hospital Del Mar
Department Name
Neurology
Contact Person Name
Ana Rodriguez Campello
Contact Person Email
ARodriguezC@parcdesalutmar.cat

Germany

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
63
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Neurology
Contact Person Name
Jan Hendrik Schäfer
Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Neurologie und Neurophysiologie
Contact Person Name
Matthias Maschke
Contact Person Email
m.maschke@bk-trier.de
Site Name
Universitaet Leipzig
Department Name
Klinik und poliklinik für Neurologie
Contact Person Name
Dominik Michalski
Site Name
Klinikum Altenburger Land GmbH
Department Name
Neurology and Neurological intensive care unit
Contact Person Name
Jörg Berrouschot
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Neurology
Contact Person Name
Georg Royl
Contact Person Email
georg.royl@uni-luebeck.de

France

Earliest CTIS Part Ii Submission Date
28-07-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
64
Number Of Sites
7
Number Of Participants
45

Sites

Site Name
CHRU De Nancy
Department Name
Neurology
Contact Person Name
Sebastien RICHARD
Contact Person Email
s.richard@chu-nancy.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neurology
Contact Person Name
Lucie DELLA SCHIAVA
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurology
Contact Person Name
Lionel CALVIERE
Contact Person Email
calviere.l@chu-toulouse.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Neurovasculaire
Contact Person Name
Marco PASI
Contact Person Email
m.pasi@chu-tours.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Vascular Neurology
Contact Person Name
Aude TRIQUNOT BAGAN
Contact Person Email
aude.triquenot@chu-rouen.fr
Site Name
Fondation A De Rothschild
Department Name
Neurovasculaire
Contact Person Name
Pierre SENERS
Contact Person Email
pseners@for.paris
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Neurologie Vasculaire
Contact Person Name
Pauline CUISENIER
Contact Person Email
pcuisenier@chu-grenoble.fr

Finland

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
39
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
HUS-Yhtymae
Department Name
Neurocenter, Stroke Trials Unit
Contact Person Name
Daniel Strbian
Contact Person Email
daniel.strbian@hus.fi

Sponsor

Primary sponsor

Full Name
Corxel Pharmaceuticals Co. Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
China

Contract research organisations

Name
Medpace Finland Oy
Responsibilities
On site monitoring, Statistical analysis, Regulatory expertise, Medical expertise, Investigator recruitment, Laboratory analysis, Project management, maintenance of QA and QC of CRO systems and processes, edata capture, safety reporting.
Name
Almac Clinical Technologies LLC
Responsibilities
3
Name
Bioclinica Inc.
Responsibilities
Medical Imaging
Name
Clinone Inc.
Responsibilities
eConsent Vendor

Third parties

  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"On site monitoring, Statistical analysis, Regulatory expertise, Medical expertise, Investigator recruitment, Laboratory analysis, Project management, maintenance of QA and QC of CRO systems and processes, edata capture, safety reporting.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"PK and Biomarker analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinone Inc.","duties_or_roles":"eConsent Vendor","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JX10
Active Substance
JX10
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Maximum Dose
300 mg
Investigational Product Name
Jx10 placebo drug product is prepared as a sterile, lyophilized white to light yellow cake or powder for infusion.
Modality
Other

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