Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
35
Countries
1
Sites
1
Combined postcapillary and precapillary pulmonary hypertension / Isolated postcapillary pulmonary hypertension
Key facts
- Sponsor
- Tectonic Therapeutic Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 8 Jul 2024 → 3 Sep 2025
- Decision date (initial)
- 2024-04-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Combined postcapillary and precapillary pulmonary hypertension / Isolated postcapillary pulmonary hypertension
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10037400 | Pulmonary hypertension | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tectonic Therapeutic Inc.
- Sponsor organisation
- Tectonic Therapeutic Inc.
- Address
- 490 Arsenal Way
- City
- Watertown
- Postcode
- 02472-2988
- Country
- United States
Scientific contact point
- Organisation
- Tectonic Therapeutic Inc.
- Contact name
- Anthony Muslin
Public contact point
- Organisation
- Tectonic Therapeutic Inc.
- Contact name
- Anthony Muslin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 10 | 1 |
| Rest of world
Moldova, Republic of, Georgia
|
— | 25 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Cardiology, Hanzeplein 1, 9713 GZ, Groningen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-07-08 | 2025-09-02 | 2024-08-21 | 2025-01-15 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-21 | Netherlands | Acceptable 2024-04-04
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-27 | Netherlands | Acceptable 2024-10-14
|
2024-10-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-28 | Netherlands | Acceptable 2025-05-13
|
2025-05-13 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-31 | Netherlands | Acceptable 2025-09-01
|
2025-09-02 |