Clinical trial • Phase II • Cardiology
TX000045 for Pulmonary hypertension | Heart failure with preserved ejection fraction (HFpEF)
Phase II trial of TX000045 for Pulmonary hypertension | Heart failure with preserved ejection fraction (HFpEF).
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Pulmonary hypertension | Heart failure with preserved ejection fraction (HFpEF)
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 02-08-2024
- First CTIS Authorization Date
- 28-11-2024
Trial design
Randomised, placebo (sterile isotonic solution) administered as the comparator arm (placebo described as 'sterile isotonic solution'). dose/schedule for comparator not specified.-controlled Phase II trial in Poland, Belgium, Austria and others.
- Randomised
- Yes
- Comparator
- Placebo (sterile isotonic solution) administered as the comparator arm (placebo described as 'sterile isotonic solution'). Dose/schedule for comparator not specified.
- Target Sample Size
- 54
- Trial Duration For Participant
- 168
Eligibility
Recruits 54 Mentally or legally incapacitated individuals are excluded per criterion: "26. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator". Only adults aged 18–83 are eligible (no paediatric participants); informed consent is obtained from adult participants. No paediatric assent procedures are specified..
- Pregnancy Exclusion
- "20. Is pregnant or breastfeeding"
- Vulnerable Population
- Mentally or legally incapacitated individuals are excluded per criterion: "26. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator". Only adults aged 18–83 are eligible (no paediatric participants); informed consent is obtained from adult participants. No paediatric assent procedures are specified.
Inclusion criteria
- {"criterion_text":"- 1. Is a male or female of non–childbearing potential between the ages of 18 and 83 years."}
- {"criterion_text":"- 2. Has a diagnosis of PH-HFpEF based on ALL the following criteria: a) The baseline echocardiogram, performed during screening, demonstrates the following: left ventricular ejection fraction (LVEF) >40%, tricuspid regurgitation gradient peak >36 mm Hg, and SPAP >41 mm Hg."}
- {"criterion_text":"- 3. Has NYHA functional class II-III heart failure"}
- {"criterion_text":"- 4. Has 6MWT distance ≥100 m and ≤450 m, repeated during screening."}
- {"criterion_text":"- 5. If the participant is receiving chronic medication for the treatment of heart failure, including diuretics, or any other cardiovascular condition (including systemic hypertension), the dose must be stable for ≥30 days before start of screening."}
Exclusion criteria
- {"criterion_text":"- 1. Has a confirmed diagnosis of PH in WHO Group 1 (pulmonary arterial hypertension), WHO Group 3 (PH associated with significant lung disease), WHO Group 4 (PH associated with chronic thromboembolic disease), or WHO Group 5"}
- {"criterion_text":"- 2. Was hospitalized for any indication within 7 days before the start of screening"}
- {"criterion_text":"- 20. Is pregnant or breastfeeding"}
- {"criterion_text":"- 22. Has a history of active malignancy within 5 years before the start of screening, except for fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or squamous cell carcinomas of the skin"}
- {"criterion_text":"- 23. Has a history of drug or alcohol abuse"}
- {"criterion_text":"- 24. Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy"}
- {"criterion_text":"- 25. Has significant orthopedic or arthritic disease that limits the ability to complete a 6MWT"}
- {"criterion_text":"- 26. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator"}
- {"criterion_text":"- 27. Has a history of any illness that, in the opinion of the investigator, poses additional risk to the participant"}
- {"criterion_text":"- 3. Received IV vasoactive therapies inotropes"}
- {"criterion_text":"- 5. Initiated a new exercise program within 90 days before the start of screening or plans to initiate such a program during the study (patients who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)"}
- {"criterion_text":"- Has documented significant lung disease"}
- {"criterion_text":"- 6. Has a body mass index (BMI) <18 kg/m2 or >50 kg/m2"}
- {"criterion_text":"- 7. Was previously administered TX000045, relaxin, or a relaxin fusion protein"}
- {"criterion_text":"- 8. Received a small molecule RXFP1 agonist within 30 days before the start of screening"}
- {"criterion_text":"- 11. Has cardiovascular comorbidities"}
- {"criterion_text":"- Has chronic liver disease (other than congestive hepatopathy), active hepatitis B infection (positive hepatitis B surface antigen and positive hepatitis B core antibodies), or hepatitis C infection (positive hepatitis C antibodies) at the screening visit. In patients with isolated positive hepatitis B core antibodies, a hepatitis B DNA test will be performed. If positive, the participant will be excluded from the study due to active hepatitis B."}
- {"criterion_text":"- 14. Has HIV infection or HIV seropositivity at the screening visit"}
- {"criterion_text":"- 15. Has an active tuberculosis infection"}
- {"criterion_text":"- 16. Has any of the following clinical laboratory values during screening: a) Serum alanine aminotransferase or aspartate aminotransferase levels >3× the upper limit of normal (ULN) or total bilirubin >3× ULN b) Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD EPI [Chronic Kidney Disease Epidemiology Collaboration] equation) or required renal replacement therapy (eg, ultrafiltration or dialysis) within 90 days before the start of screening c) HbA1c (glycosylated hemoglobin) >9% d) Platelet count <50,000/mm3 e) Hemoglobin <10.0g/dL"}
- {"criterion_text":"- 17. Has a history of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product"}
- {"criterion_text":"- 18. Had major surgery within 60 days before the start of screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean change from baseline to Week 24 in PVR as measured by right heart catheterization (RHC) in participants with baseline PVR ≥3 Wood units who received TX000045 compared with those who received placebo","definition_or_measurement_approach":"PVR measured by right heart catheterization (RHC); endpoint is mean change from baseline to Week 24 in participants with baseline PVR ≥3 Wood units comparing TX000045 vs placebo."}
- {"endpoint_text":"- In participants who received TX000045 compared with placebo, describe: • Incidence of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) • Incidence of clinically significant changes from baseline in laboratory assessments, 12-lead electrocardiogram (ECG), vital sign assessments, and physical examinations","definition_or_measurement_approach":"Safety endpoints reported as incidence counts/rates: AEs, AESIs, SAEs, and clinically significant changes in laboratory assessments, 12-lead ECG, vital signs, and physical examinations."}
Secondary endpoints
- {"endpoint_text":"- Mean change from baseline to Week 24 in PVR as measured by right heart catheterization (RHC) in participants with baseline PVR ≥3 Wood units who received TX000045 compared with those who received placebo","definition_or_measurement_approach":"Same measurement as primary: PVR measured by RHC; mean change baseline to Week 24 comparing TX000045 vs placebo."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 54
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent is obtained from adult participants (eligible ages 18–83). Subject information and ICF main adult documents are provided (L1 SIS and ICF Main Adult) and pregnancy-partner information documents are available where applicable. Consent materials and subject information are available in multiple languages (examples in the document list: English, Polish, Spanish, German, Bulgarian, Romanian, Portuguese, Latvian and others). No paediatric assent procedures are specified.
Methods
- Digital ads – recruitment materials referenced as 'Digital Ads' (K2 documents).
- Referral letters – 'Referral letter screened and randomized patient' and 'Referral letter randomized patient' materials available in multiple languages.
- Patient-facing printed materials – patient study guide, patient study brochure, patient fact cards, patient study poster (K2 materials).
- Informed Consent Flipbook – used as recruitment/support material.
- Patient emergency/alert card and participant-facing materials (L2).
- Referral fee/payment per randomized or screened-and-randomized patient (country-specific documents referenced).
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 201
Poland
- Earliest CTIS Part Ii Submission Date
- 25-10-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 38
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Klinika Kardiologii
- Contact Person Name
- Michał Tomaszewski
- Contact Person Email
- szpital@spsk4.lublin.pl
- Site Name
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Department Name
- Klinika Wad Wrodzonych Serca
- Principal Investigator Email
- miroslaw.kowalski@ikard.pl
- Contact Person Name
- Mirosław Kowalski
- Contact Person Email
- miroslaw.kowalski@ikard.pl
- Site Name
- Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
- Department Name
- Oddział Kardiologiczny
- Principal Investigator Email
- radoslaw.krecki@scanmed.pl
- Contact Person Name
- Radosław Kręcki
- Contact Person Email
- radoslaw.krecki@scanmed.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Email
- sekr_kard@szpitaljp2.krakow.pl
- Contact Person Name
- Grzegorz Kopeć
- Contact Person Email
- sekr_kard@szpitaljp2.krakow.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Kardiologii i Chorób Wewnętrznych z OINK
- Principal Investigator Email
- kardio@uskwb.pl
- Contact Person Name
- Karol Kamiński
- Contact Person Email
- kardio@uskwb.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego we Wrocławiu
- Principal Investigator Email
- dr.piotr.gajewski@gmail.com
- Contact Person Name
- Piotr Gajewski
- Contact Person Email
- dr.piotr.gajewski@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-02-2025
- Latest Decision Or Authorization Date
- 05-03-2025
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Ziekenhuis Oost Limburg
- Department Name
- Cardiology
- Contact Person Name
- Pieter Martens
- Contact Person Email
- pieter.martens2@zol.be
- Site Name
- Hopital Erasme
- Department Name
- Cardiology
- Principal Investigator Email
- celine.dewachter@hubruxelles.be
- Contact Person Name
- Céline Dewachter
- Contact Person Email
- celine.dewachter@hubruxelles.be
Austria
- Earliest CTIS Part Ii Submission Date
- 20-11-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Klinik Favoriten 5. Medizinische Abteilung mit Kardiologie
- Department Name
- Kardiologie
- Principal Investigator Name
- Diana Bonderman
- Principal Investigator Email
- diana.bonderman@meduniwien.ac.at
- Contact Person Name
- Diana Bonderman
- Contact Person Email
- diana.bonderman@meduniwien.ac.at
Romania
- Earliest CTIS Part Ii Submission Date
- 26-11-2024
- Latest Decision Or Authorization Date
- 19-02-2025
- Processing Time Days
- 85
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Spitalul Clinic Judetean De Urgenta Targu Mures
- Department Name
- Cardiology
- Principal Investigator Email
- theodora.benedek@umfst.ro
- Contact Person Name
- Theodora Mariana Nicoleta Benedek
- Contact Person Email
- theodora.benedek@umfst.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Craiova
- Department Name
- Cardiology
- Principal Investigator Name
- Octavian Istratoaie
- Principal Investigator Email
- info@scju.ro
- Contact Person Name
- Octavian Istratoaie
- Contact Person Email
- info@scju.ro
- Site Name
- Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu
- Department Name
- Cardiology 3
- Principal Investigator Email
- cardiologie.fundeni@umfcd.ro
- Contact Person Name
- Bogdan Alexandru Popescu
- Contact Person Email
- cardiologie.fundeni@umfcd.ro
Germany
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 28-11-2024
- Processing Time Days
- 45
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Cardiology
- Principal Investigator Name
- Christina Magnussen
- Principal Investigator Email
- c.magnussen@uke.de
- Contact Person Name
- Christina Magnussen
- Contact Person Email
- c.magnussen@uke.de
- Site Name
- Universitätsmedizin der Johannes Gutenberg Universität Mainz
- Department Name
- Zentrum für Kardiologie
- Principal Investigator Email
- kai_helge.schmidt@unimedizin-mainz.de
- Contact Person Name
- Kai Helge Schmidt
- Contact Person Email
- kai_helge.schmidt@unimedizin-mainz.de
- Site Name
- Sana-Klinikum Remscheid GmbH
- Department Name
- Medizinische Klinik I Kardiologie, Angiologie, Pneumologie, Nephrologie, Intensivmedizin
- Principal Investigator Name
- Burkhard Sievers
- Principal Investigator Email
- burkhard.sievers@sana.de
- Contact Person Name
- Burkhard Sievers
- Contact Person Email
- burkhard.sievers@sana.de
Spain
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 28-11-2024
- Processing Time Days
- 16
- Number Of Sites
- 9
- Number Of Participants
- 24
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Advanced Heart Faulire Unit
- Principal Investigator Name
- Susana Del Prado
- Principal Investigator Email
- docsusana10@gmail.com
- Contact Person Name
- Susana Del Prado
- Contact Person Email
- docsusana10@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Cardiology
- Principal Investigator Name
- Eduardo Ródenas Alesina
- Principal Investigator Email
- eduard.rodenas@valldhebron.cat
- Contact Person Name
- Eduardo Ródenas Alesina
- Contact Person Email
- eduard.rodenas@valldhebron.cat
- Site Name
- Hospital 9 De Octubre S.A.
- Department Name
- Cardiology
- Principal Investigator Name
- Ignacio Jose Sánchez Lázaro
- Principal Investigator Email
- ignacio.sanchez@vithas.es
- Contact Person Name
- Ignacio Jose Sánchez Lázaro
- Contact Person Email
- ignacio.sanchez@vithas.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Cardiology
- Principal Investigator Name
- María Álvarez Barredo
- Principal Investigator Email
- mariaalvarezba@hotmail.com
- Contact Person Name
- María Álvarez Barredo
- Contact Person Email
- mariaalvarezba@hotmail.com
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Pulmonary Hypertension Unit
- Principal Investigator Name
- María Lázaro Salvador
- Principal Investigator Email
- maria.lasal@gmail.com
- Contact Person Name
- María Lázaro Salvador
- Contact Person Email
- maria.lasal@gmail.com
- Site Name
- Hospital Costa Del Sol
- Department Name
- Cardiology
- Principal Investigator Name
- Rafael Bravo Marqués
- Principal Investigator Email
- rafabravomarques@gmail.com
- Contact Person Name
- Rafael Bravo Marqués
- Contact Person Email
- rafabravomarques@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Cardiology
- Principal Investigator Name
- Julio Núñez
- Principal Investigator Email
- yulnunez@gmail.com
- Contact Person Name
- Julio Núñez
- Contact Person Email
- yulnunez@gmail.com
- Site Name
- Hospital 9 De Octubre S.A.
- Department Name
- Cardiology
- Principal Investigator Name
- Ignacio José Sánchez Lázaro
- Principal Investigator Email
- ignacio.sanchez@vithas.es
- Contact Person Name
- Ignacio José Sánchez Lázaro
- Contact Person Email
- ignacio.sanchez@vithas.es
- Site Name
- Hospital 9 De Octubre S.A.
- Department Name
- Cardiology
- Contact Person Name
- Ignacio José Sánchez Lázaro
- Contact Person Email
- ignacio.sanchez@vithas.es
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 28-11-2024
- Processing Time Days
- 10
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Clinic of Cardiology
- Principal Investigator Name
- Snezhanka Tisheva- Gospodinova
- Principal Investigator Email
- doctisheva@abv.bg
- Contact Person Name
- Snezhanka Tisheva- Gospodinova
- Contact Person Email
- doctisheva@abv.bg
- Site Name
- University Hospital St. Anna
- Department Name
- Clinic of Internal Diseases
- Principal Investigator Name
- Dimitar Raev
- Principal Investigator Email
- draevbg56@yahoo.com
- Contact Person Name
- Dimitar Raev
- Contact Person Email
- draevbg56@yahoo.com
- Site Name
- Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD
- Department Name
- First Clinic of Cardiology
- Principal Investigator Name
- Ivo Petrov
- Principal Investigator Email
- petrovivo@hotmail.com
- Contact Person Name
- Ivo Petrov
- Contact Person Email
- petrovivo@hotmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Interventional Cardiology Department
- Principal Investigator Name
- Krasimir Dzhinsov
- Principal Investigator Email
- dr.krasimir.djinsov@gmail.com
- Contact Person Name
- Krasimir Dzhinsov
- Contact Person Email
- dr.krasimir.djinsov@gmail.com
Latvia
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 20-03-2025
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Andris Skride
- Principal Investigator Email
- info@healthtravellatvia.lv
- Contact Person Name
- Andris Skride
- Contact Person Email
- info@healthtravellatvia.lv
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 48
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Cardiology
- Principal Investigator Name
- Filipa Ferreira
- Principal Investigator Email
- filipa.ferreira@hgo.min-saude.pt
- Contact Person Name
- Filipa Ferreira
- Contact Person Email
- filipa.ferreira@hgo.min-saude.pt
- Site Name
- Hospital De Santa Maria E.P.E.
- Department Name
- Cardiology
- Principal Investigator Name
- Rui Plácido
- Principal Investigator Email
- rui.placido@chln.min-saude.pt
- Contact Person Name
- Rui Plácido
- Contact Person Email
- rui.placido@chln.min-saude.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Cardiology
- Principal Investigator Name
- Mário Santos
- Principal Investigator Email
- geral.investigacao.defi@chporto.min-saude.pt
- Contact Person Name
- Mário Santos
- Contact Person Email
- geral.investigacao.defi@chporto.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Tectonic Therapeutic Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Novotech Clinical Research (Cyprus) Limited
- Responsibilities
- Regulatory and clinical operations support (sponsorDuties codes: 1,10,11,12,5,6,8); contact Europe.regulatory@novotech-cro.com
- Name
- Sonic Clinical Trials Pty Limited
- Responsibilities
- Laboratory/clinical testing support (sponsorDuties: code 5); contact JThai@sonicclinicaltrials.com
- Name
- Voiant LLC
- Responsibilities
- Clinical operations support (sponsorDuties: code 5); contact smarroquin@voiantclinical.com
- Name
- Bioclinica Inc.
- Responsibilities
- ECHO and laboratory support (sponsorDuties: ECHO, code 5); contact Aesha.Vyas@clario.com
- Name
- Innovative Trials Limited
- Responsibilities
- Patient facing materials; contact emma.coulthard@innovativetrials.co.uk
Third parties
- {"country":"Cyprus","full_name":"Novotech Clinical Research (Cyprus) Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6,8; contact email: Europe.regulatory@novotech-cro.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties: code 15 (patients diary); contact email: kelie.taylor@clario.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Myonex Limited","duties_or_roles":"sponsorDuties codes: 14,5; contact email: DistributionUK@myonex.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"sponsorDuties code 15 (Patient Facing Materials); contact email: emma.coulthard@innovativetrials.co.uk","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties: code 15 (eCRF); contact email: helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties: code 15 (IRT); contact email: helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Myonex GmbH","duties_or_roles":"sponsorDuties: code 15 (Other - Storage of IMP, Distribution); contact email: sdittmann@myonex.com","organisation_type":"Pharmaceutical company"}
- {"country":"Australia","full_name":"Sonic Clinical Trials Pty Limited","duties_or_roles":"sponsorDuties: code 5; contact email: JThai@sonicclinicaltrials.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"sponsorDuties: code 5; contact email: smarroquin@voiantclinical.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"sponsorDuties: code 4; contact email: JThai@sonicclinicaltrials.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties: code 15 (ECHO), code 5; contact email: Aesha.Vyas@clario.com","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- TX000045
- Active Substance
- TX000045
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- MIA number IMP12234/00001
- Maximum Dose
- 300 mg (maxDailyDoseAmount: 300 mg)
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