Clinical trial • Phase II/III • Neurology

rinvecalinase alfa for Acute ischemic stroke

Phase II/III trial of rinvecalinase alfa for Acute ischemic stroke.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Acute ischemic stroke
Trial Stage
Phase II/III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
31-07-2025
First CTIS Authorization Date
25-11-2025

Trial design

Randomised, active: dm199 (rinvecalinase alfa) - solution for injection (investigational product, mia number imp12798/00001). product details in part i list dose units µg with max daily dose amount 548 µg and max total dose amount 3536 µg; max treatment period 21 days. comparator: centrally blinded placebo product described as 'centrally blinded product containing all the same manufactured ingredients and excipients as the dm199 formulation, except for the active pharmaceutical ingredient (api).' exact dosing schedule and active treatment regimen specifics are not detailed in the provided record.-controlled, adaptive Phase II/III trial in Belgium, France, Hungary and others.

Randomised
Yes
Comparator
Active: DM199 (rinvecalinase alfa) - solution for injection (investigational product, MIA number IMP12798/00001). Product details in Part I list dose units µg with max daily dose amount 548 µg and max total dose amount 3536 µg; max treatment period 21 days. Comparator: centrally blinded placebo product described as 'centrally blinded product containing all the same manufactured ingredients and excipients as the DM199 formulation, except for the active pharmaceutical ingredient (API).' Exact dosing schedule and active treatment regimen specifics are not detailed in the provided record.
Adaptive
True, Adaptive design is specified in the study title; no further adaptive rules (dose-escalation schema, interim analysis details, stopping rules) are described in the provided CTIS extract.
Target Sample Size
628
Trial Duration For Participant
90

Eligibility

Recruits 628 Legally authorized representative may provide informed consent on behalf of participant (inclusion criteria states: 'Participant and/or legally authorized representative is able to provide informed consent'). The CTIS documentation includes multiple language versions of ICFs; no paediatric participants are eligible (inclusion requires age 18–90). The trial listing does not mark vulnerable population selected; consent from legally authorized representative is explicitly permitted where applicable..

Pregnancy Exclusion
Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator.
Vulnerable Population
Legally authorized representative may provide informed consent on behalf of participant (inclusion criteria states: 'Participant and/or legally authorized representative is able to provide informed consent'). The CTIS documentation includes multiple language versions of ICFs; no paediatric participants are eligible (inclusion requires age 18–90). The trial listing does not mark vulnerable population selected; consent from legally authorized representative is explicitly permitted where applicable.

Inclusion criteria

  • {"criterion_text":"- Participant is between 18 and 90 years of age inclusive."}
  • {"criterion_text":"- Participant weight is 40 kg to 166 kg inclusive."}
  • {"criterion_text":"- Participant to be randomized and infusion with investigational product initiated within 24 hours of last known normal/AIS stroke onset."}
  • {"criterion_text":"- Participant has NIHSS ≥5 and ≤15 at approximately the time of randomization. This criterion also applies to participants who meet the following conditions: • The participant initially presents with an NIHSS score below 5, but clinically worsens, including cases of progressing stroke/stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and • Participant meets all other inclusion and exclusion criteria, including repeat brain imaging to rule out hemorrhagic transformation."}
  • {"criterion_text":"- Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant’s representative."}
  • {"criterion_text":"- If participant has received fibrinolytic treatment for AIS within 4.5 hours of last known normal/AIS stroke onset and at least 6 hours after completing fibrinolytic treatment, and the participant meets all of the following criteria: • Participant’s initial NIHSS score prior to fibrinolytics was ≤15; and • At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and • The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and • Participant meets all other inclusion and exclusion criteria including repeat brain imaging to rule out hemorrhagic transformation. Hemorrhagic transformation is defined as any of the following: ▪ PH1 or PH2 type hemorrhage based on Heidelberg Classification ▪ Hemorrhage resulting in neurologic deterioration Note: HI1 and HI2 type hemorrhages based on Heidelberg classification are not exclusionary."}
  • {"criterion_text":"- Participant and/or legally authorized representative is able to provide informed consent."}
  • {"criterion_text":"- Participant is willing and able to comply with the study protocol, in the Investigator's judgment."}

Exclusion criteria

  • {"criterion_text":"- At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhagic stroke."}
  • {"criterion_text":"- Participant has a history of clinically significant allergic reactions such as angioedema or anaphylaxis requiring hospitalization."}
  • {"criterion_text":"- Participant has a diagnosis or suspected diagnosis of hereditary angioedema (HAE) or is taking or prescribed medications commonly used as prophylaxis/treatment of HAE, such as C1-esterase inhibitors (Cinryze, Berinert, Ruconest, Haegarda), Danazol, kallikrein inhibitors (Ecallantide, Berotralstat, Lanadelumab), Bradykinin B2 Receptor Antagonists (Icatibant), or other medication designed to influence the kallikrein-kinin system."}
  • {"criterion_text":"- Life expectancy estimated at ≤1 year prior to enrollment."}
  • {"criterion_text":"- Participant has clinical evidence of an active infection at the time of enrollment requiring parenteral treatment or hospitalization to monitor or manage the infection. NOTE: Treatment of uncomplicated infections with oral antibiotics would not be an exclusion (example treatment of an uncomplicated urinary tract infection or sinus infections with oral antibiotics would not be an exclusion)."}
  • {"criterion_text":"- Participant has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency)."}
  • {"criterion_text":"- Participant is pregnant or nursing. NOTE: Participants who agree to stop nursing may be considered for inclusion at the discretion of the Investigator."}
  • {"criterion_text":"- Participants of child-bearing potential who do not agree to use medically acceptable contraceptive measures to prevent pregnancy. All participants of childbearing potential (defined as sexually mature participants who have had menses within the preceding 24 months and have not undergone permanent sterilization methods such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, etc.) must have a negative serum pregnancy test performed locally at screening. Participants of childbearing potential must agree not to attempt to become pregnant or undergo in vitro fertilization. If participating in sexual activity that could lead to pregnancy, participants must use 2 reliable methods (1 per partner is acceptable) of contraception simultaneously while receiving protocol-specified medication and during the study follow-up period. Participants participating in sexual activity must agree to use, or for their partner to use highly effective birth control methods (those with a failure rate of less than 1% per year when used consistently and correctly) until they have completed the study (after the Day 90 visit). Such methods include: • Combined (estrogen and progesterone containing) hormonal oral, intravaginal, or transdermal contraception associated with the inhibition of ovulation • Progesterone-only oral, injectable, or implantable hormonal contraception associated with the inhibition of ovulation • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence Participants who are not of reproductive potential (who have been postmenopausal for more than 24 consecutive months or have undergone hysterectomy, bilateral oophorectomy) are not required to use contraception. Participants are prohibited from sperm donation. NOTE: A negative serum pregnancy test will be documented during screening if a participant is of child-bearing potential."}
  • {"criterion_text":"- Participant is currently participating in or has participated in a study using an investigational device or drug or received an investigational drug or investigational use of a licensed drug within 30 days prior to screening."}
  • {"criterion_text":"- Participant does not have sufficient venous access for infusion of investigational product or blood sampling."}
  • {"criterion_text":"- Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits."}
  • {"criterion_text":"- Participant has image findings with symptomatic large vessel occlusion at one or more of the following locations: Intracranial carotid I/T/L or M1 segment MCA, vertebral or basilar artery (BA)."}
  • {"criterion_text":"- Participant has any other medical condition (such as hemodialysis) which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results."}
  • {"criterion_text":"- Participant has large core of established infarction defined as ASPECTS 0-5."}
  • {"criterion_text":"- Participant has or will receive MT for their current AIS. Diagnostic angiogram without proceeding to MT is not exclusionary"}
  • {"criterion_text":"- Participant has suspected or confirmed extracranial arterial dissection."}
  • {"criterion_text":"- Participant has imaging findings and symptoms consistent with a brain stem or cerebellar stroke. Posterior cerebral artery strokes without any associated brain stem or cerebellar involvement are allowable."}
  • {"criterion_text":"- Participant has 2 consecutive recorded measurements of SBP < 100 mm Hg or MAP <65 mm Hg; MAP = DBP + [1/3 (SBP – DBP)] after stroke symptom onset and within 6 hours prior to randomization."}
  • {"criterion_text":"- Participant is currently prescribed angiotensin-converting enzyme inhibitor (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment through Day 29 ±1 day (8 days after last treatment)."}
  • {"criterion_text":"- Participant is currently prescribed an ACEi, and the last reported dose by the participant or their representative: • was taken less than 24 hours prior to the start of IV IP infusion for participants with normal or mild kidney disease (CKD 1-3a [eGFR ≥ 45 mL/min/1.73 m²]), or • was taken less than 48 hours prior to the start of IV IP infusion for participants with significant kidney disease (CKD 3b or higher [eGFR < 45 mL/min/1.73 m²])"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Stroke recovery as defined by participants with excellent functional outcomes at Day 90 as assessed via the modified Rankin Score (mRS [dichotomized]), mRS scores of 0 or 1 represent responders, scale range of 0–6.","definition_or_measurement_approach":"mRS dichotomized at Day 90; responders defined as mRS 0 or 1."}
  • {"endpoint_text":"- Incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs).","definition_or_measurement_approach":"Collection and assessment of AEs and SAEs with incidence, severity and investigator-assessed causality."}
  • {"endpoint_text":"- Incidence, severity, and causality of adverse events of special interest (AESI).","definition_or_measurement_approach":"Collection and assessment of AESIs with incidence, severity and causality assessment."}
  • {"endpoint_text":"- Tolerability (incidence and severity of injection site adverse reactions).","definition_or_measurement_approach":"Recording of injection-site reactions with incidence and severity grading."}
  • {"endpoint_text":"- Change from Baseline in physical examination (PE) at Day 21 and Day 90.","definition_or_measurement_approach":"Comparison of physical examination findings at Day 21 and Day 90 versus baseline."}
  • {"endpoint_text":"- Change from Baseline in vital sign measurements (resting heart rate (HR), systolic/diastolic blood pressure (BP), respiratory rate (RR), and body temperature (BT)) at Days 1, 4, 21, and 90.","definition_or_measurement_approach":"Vital signs measured at listed visits and change from baseline calculated."}
  • {"endpoint_text":"- Change from Baseline in hematology and chemistry parameters at Day 4, Day 21, and Day 90.","definition_or_measurement_approach":"Laboratory hematology and chemistry panels collected at Days 4, 21, 90 and compared to baseline."}
  • {"endpoint_text":"- Change from baseline in 12-lead Electrocardiogram (ECG) at Day 1 and Day 90 as determined by the Investigator.","definition_or_measurement_approach":"12-lead ECGs at Day 1 and Day 90 assessed by investigator for changes vs baseline."}

Secondary endpoints

  • {"endpoint_text":"- Assessment of effect on disability across the full spectrum of AIS by examining the distribution of mRS (shift) scores (scale range = 0 to 6) at Day 90.","definition_or_measurement_approach":"Ordinal (shift) analysis of the full distribution of mRS scores at Day 90."}
  • {"endpoint_text":"- Proportion of participants achieving independent function (able to look after their own affairs without assistance) with or without minor disability at Day 90 assessed as mRS 0-2 (dichotomized). mRS scores of 0, 1, or 2 represent responders, scale range of 0–6.","definition_or_measurement_approach":"Dichotomized mRS (0–2) at Day 90; proportion of responders computed."}
  • {"endpoint_text":"- Mortality rate as defined by event rate (%) for mortality over 90 days.","definition_or_measurement_approach":"All-cause mortality event rate (%) measured through Day 90."}
  • {"endpoint_text":"- Proportion of participants achieving an excellent neurological outcome defined by NIHSS = 0-1 (dichotomized) (NIHSS scores of 0 or 1, scale range 0 to 42) at Day 90.","definition_or_measurement_approach":"Dichotomized NIHSS (0–1) at Day 90; proportion achieving NIHSS 0–1."}
  • {"endpoint_text":"- Proportion of participants achieving an excellent functional independence in activities of daily living defined by Barthel Index score (dichotomized) greater than or equal to 95 (scale range 0 to 100) at Day 90.","definition_or_measurement_approach":"Barthel Index measured at Day 90; proportion with score ≥95."}
  • {"endpoint_text":"- Recurrent AIS as defined by proportion of participants who experience a recurrent AIS by Day 90 as assessed by a new, persistent neurological deficit attributable to cerebrovascular ischemia. Imaging findings, if available, should support the diagnosis.","definition_or_measurement_approach":"New persistent neurological deficit attributable to cerebrovascular ischemia by Day 90; imaging to support diagnosis when available."}

Recruitment

Digital Remote Recruitment
True, recruitment-related documents include 'Scout Email Communication' and 'Reloadable ScoutPass Mailer' (France) and electronic/print study brochures and email communications in other Member States, indicating use of digital/remote channels; specific procedures/content not included in JSON.
Planned Sample Size
628
Recruitment Window Months
12
Consent Approach
Informed consent must be provided by the participant or the participant's legally authorized representative ('Participant and/or legally authorized representative is able to provide informed consent'). Multiple language versions of subject information and ICF documents are provided in the dossier (examples: English, Belgian Dutch (BE_NL), Belgian French (BE_FR), French, Hungarian, Romanian, Spanish, Polish). A specific ICF for 'Pregnant Partner' is present; a child PIS/ICF file exists in the France documents but the study inclusion requires participants 18–90 years so paediatric assent is not applicable for enrolment.

Methods

  • K1_Recruitment arrangements (country-specific recruitment arrangement documents uploaded for several Member States) — document titles available in the CTIS dossier but content not provided in the JSON.
  • Scout Email Communication (France) — document title indicates email communication channel for Scout recruitment materials (France).
  • Reloadable ScoutPass Mailer / ScoutPass Brochure (France) — document titles indicate use of a reloadable mailer/brochure as part of recruitment materials.
  • Study brochures / infographics / participant ID card / participant treatment diary (multiple countries) — participant-facing materials uploaded for recruitment/information (titles present in dossier for BE, FR, HU, RO, ES, PL).

Geography

Total Number Of Sites
35
Total Number Of Participants
100

Belgium

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
29
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Jessa Ziekenhuis
Department Name
Neurology Department
Contact Person Name
Koen Delmotte
Contact Person Email
Koen.Delmotte@jessazh.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Neurology Department
Contact Person Name
Peter Vanacker
Contact Person Email
PETER.VANACKER@azgroeninge.be
Site Name
Imelda
Department Name
Neurology Department
Contact Person Name
Laurens Dobbels
Contact Person Email
Laurens.Dobbels@imelda.be
Site Name
Clinique Saint-Pierre
Department Name
Neurology Department
Contact Person Name
Jean-Marc Raymackers
Contact Person Email
jean-marc.raymackers@cspo.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Neurology Department
Contact Person Name
Dimitri Hemelsoet
Contact Person Email
dimitri.hemelsoet@uzgent.be
Site Name
CHC MontLegia
Department Name
Neurology Department
Contact Person Name
Philippe Desfontaines
Contact Person Email
philippe.desfontaines@chc.be

France

Earliest CTIS Part Ii Submission Date
11-11-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
17
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Pellegrin Hospital
Department Name
Unité Neurovasculaire
Contact Person Name
Igor Sibon
Contact Person Email
Igor.sibon@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hopital Timone - Service de Neurologie
Contact Person Name
Emilie Doche
Contact Person Email
Emilie.doche@ap-hm.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hopiltal de Hautepierre - Unité Neurovasculaire
Contact Person Name
Valérie Wolff
Site Name
CHRU De Nancy
Department Name
Unité Neurovasculaire
Contact Person Name
Sébastien Richard
Contact Person Email
s.richard@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
PONTCHAILLOU Hospital - Unité de Neurovasculaire
Contact Person Name
Stéphane Vannier
Contact Person Email
stephane.vannier@chu-rennes.fr

Hungary

Earliest CTIS Part Ii Submission Date
06-11-2025
Latest Decision Or Authorization Date
26-11-2025
Processing Time Days
20
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Stroke, Neurology and Toxicology Department
Contact Person Name
Attila Valikovics
Site Name
Szent Damjan Goeroegkatolikus Korhaz
Department Name
Neurology and Stroke Department
Contact Person Name
Marina Czurkó
Contact Person Email
dr.czurkomarina@gmail.com
Site Name
Hatvani Albert Schweitzer Korhaz-Rendelointezet
Department Name
Neurology Department
Contact Person Name
Krisztián Pozsegovits
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Neurology Department
Contact Person Name
Attila Csányi
Contact Person Email
csanyia@petz.gyor.hu
Site Name
Eszak-Budai Szent Janos Centrumkorhaz
Department Name
Neurology Department
Contact Person Name
András Folyovich
Site Name
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Department Name
Neurology Department
Contact Person Name
Ildikó Vastagh
Contact Person Email
vastagh.ildiko@bajcsy.hu
Site Name
Additional Hungarian site (listed)
Department Name
Neurology Department
Contact Person Name
Krisztián Pozsegovits

Romania

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
16
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Department Name
Sectia Clinica Neurologie
Contact Person Name
Any Axelerad
Contact Person Email
docuaxi@yahoo.com
Site Name
Institutul Clinic Fundeni
Department Name
Sectia Neurologie I
Contact Person Name
Octaviana-Adriana Dulamea
Contact Person Email
octaviana.dulamea@umfcd.ro
Site Name
Elias University Emergency Hospital
Department Name
Sectia Clinica Neurologie
Contact Person Name
Cristina Aura Panea
Contact Person Email
cristina.panea@umfcd.ro

Spain

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
21
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology Department
Contact Person Name
Carlos Molina Cateriano
Contact Person Email
carlosav.molina@vallhebron.cat
Site Name
Hospital General Universitario De Albacete
Department Name
Neurology Department
Contact Person Name
Tomás Segura Martín
Contact Person Email
tseguram@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Neurology Department
Contact Person Name
Marina Martínez Sánchez
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Neurology Department
Contact Person Name
María del Mar Castellanos Rodrigo
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Neurology Department
Contact Person Name
Manuel Rodríguez Yañez

Poland

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
30-11-2025
Processing Time Days
37
Number Of Sites
9
Number Of Participants
27

Sites

Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
Neurology with Stroke Unit
Contact Person Name
Adam Wiśniewski
Contact Person Email
adam.lek@wp.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
Neurology with Storke Unit
Contact Person Name
Bartłomiej Mielcarek
Contact Person Email
cwbk@4wsk.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Neurology
Contact Person Name
Adam Stępień
Contact Person Email
badaniakliniczne@wim.mil.pl
Site Name
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Department Name
Neurology with Storke Unit and Neuroradiological Unit
Contact Person Name
Anetta Lasek-Bal
Contact Person Email
neurologia@gcm.pl
Site Name
Szpital Czerniakowski Sp. z o.o.
Department Name
Neurology with Stroke Unit
Contact Person Name
Jarosław Pniewski
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Neurology
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych I Administracji W Poznaniu Im. Prof. Ludwika Bierkowskiego
Department Name
Neurology with Stroke Unit
Contact Person Name
Jan Ilkowski
Contact Person Email
janilkowski@poczta.onet.pl
Site Name
Szpital Uniwersytecki Imienia Karola Marcinkowskiego W Zielonej Gorze Sp. z o.o.
Department Name
Neurology with Stroke Unit
Contact Person Name
Szymon Jurga
Contact Person Email
szumon.jurga@vp.pl
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Neurology with Stroke Unit
Contact Person Name
Magdalena Targosz-Gajniak
Contact Person Email
m.targosz.gajniak@gmail.com

Sponsor

Primary sponsor

Full Name
Diamedica Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Catalyst Clinical Research LLC
Responsibilities
Preparation of SUSAR, Maintenance of Safety Database
Name
Kcas LLC
Responsibilities
Sponsor duty code: 4 (responsibility text not supplied)
Name
Global Clinical Trials LLC
Responsibilities
Multiple sponsor duty codes (1,12,2,5,8) - specific textual responsibilities not supplied
Name
LabConnect GmbH
Responsibilities
Sponsor duty code: 4 (responsibility text not supplied)
Name
Target Health LLC
Responsibilities
Sponsor duty codes: 3,6,7 (responsibility text not supplied)
Name
Global Research Ct S.R.L.
Responsibilities
Legal representative

Third parties

  • {"country":"United States","full_name":"Catalyst Clinical Research LLC","duties_or_roles":"Preparation of SUSAR, Maintenance of Safety Database","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"Sponsor duty codes: 4 (no textual duty provided in JSON)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Global Clinical Trials LLC","duties_or_roles":"Sponsor duty codes: 1, 12, 2, 5, 8 (no textual duties provided in JSON)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"Sponsor duty code: 4 (no textual duty provided in JSON)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Target Health LLC","duties_or_roles":"Sponsor duty codes: 3, 6, 7 (no textual duties provided in JSON)","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Global Research Ct S.R.L.","duties_or_roles":"Legal representative","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DM199 (rinvecalinase alfa)
Active Substance
rinvecalinase alfa
Modality
Peptide/protein/enzyme
Routes Of Administration
Parenteral use (infusion)
Route
Parenteral (infusion)
Authorisation Status
Investigational medicinal product (MIA number IMP12798/00001); no marketing authorisation indicated in product entry
Maximum Dose
Max daily dose 548 µg; max total dose 3536 µg
Investigational Product Name
Centrally blinded placebo (formulation matching DM199 excipients without API)
Modality
Other
Authorisation Status
Placebo for trial use (no marketing authorisation)

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