Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
34
Countries
5
Sites
17
Pulmonary arterial hypertension
Key facts
- Sponsor
- 35Pharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pulmonary arterial hypertension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064911 | Pulmonary arterial hypertension | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
35Pharma Inc.
- Sponsor organisation
- 35Pharma Inc.
- Address
- 750 Saint-Laurent Boulevard Suite 101
- City
- Montreal
- Postcode
- H2Y 2Z4
- Country
- Canada
Scientific contact point
- Organisation
- 35Pharma Inc.
- Contact name
- George Georges
Public contact point
- Organisation
- 35Pharma Inc.
- Contact name
- Monique Champagne
Locations
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 3 | 2 |
| Germany | Authorised, recruitment pending | 3 | 2 |
| Hungary | Authorised, recruitment pending | 2 | 2 |
| Poland | Authorised, recruitment pending | 2 | 2 |
| Spain | Authorised, recruitment pending | 7 | 9 |
| Rest of world
Canada, United Kingdom, United States
|
— | 17 | — |
Investigational sites
Institute For Clinical And Experimental Medicine
Cardiology, Videnska 1958/9, Krc, Prague
Vseobecna Fakultni Nemocnice V Praze
Cardiology, U Nemocnice 499/2, Nove Mesto, Prague
Thoraxklinik Heidelberg gGmbH
Centre for pulmonary hypertension, Roentgenstrasse 1, Rohrbach, Heidelberg
Universitaetsmedizin Greifswald KöR
Department of Internal Medicine, Respiratory Medicine and Infectious Diseases, -, 17475, Greifswald
Semmelweis University
Internal Medicine and Oncology, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
University Of Szeged
Clinical Pharmacology, Semmelweis Utca 8, 6725, Szeged
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Kardiologii, Farmakologii Klinicznej i Chorób Wewnętrznych, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department of Cardiac and Vascular Diseases, Ul. Pradnicka 80, 31-202, Cracow
Hospital Clinic De Barcelona
Pulmonology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Virgen De La Macarena
Cardiology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario De Toledo
Cardiology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario Marques De Valdecilla
Pneumology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari Vall D Hebron
Pneumology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Costa Del Sol
Cardiology, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario La Paz
Pulmonology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Cardiology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario De Salamanca
Pulmonology, Paseo De San Vicente 58-182, 37007, Salamanca
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-05 | Spain | Acceptable 2025-12-19
|
2025-12-23 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2026-01-09 | Acceptable 2025-12-19
|
2026-03-20 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-12 | Acceptable | 2026-03-02 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-01-13 | Acceptable 2025-12-19
|
2026-04-07 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-13 | Acceptable | 2026-02-13 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-14 | Spain | Acceptable | 2026-02-06 |