Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
112
Countries
1
Sites
1
Sexual Transmitted Infection (STI)
Key facts
- Sponsor
- Debiopharm International S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 18 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519328-26-01
- WHO UTN
- U1111-1315-2035
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Sexual Transmitted Infection (STI)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10018612 | Gonorrhoea | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Debiopharm International S.A.
- Sponsor organisation
- Debiopharm International S.A.
- Address
- Forum Apres-Demain, Chemin Messidor 5-7 Chemin Messidor 5-7
- City
- Lausanne
- Postcode
- 1006
- Country
- Switzerland
Scientific contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- -
Public contact point
- Organisation
- Debiopharm International S.A.
- Contact name
- -
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 112 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Belgium | 2025-06-18 | 2025-06-18 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-10 | Belgium | Acceptable with conditions 2025-05-23
|
2025-06-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-10 | Belgium | Acceptable with conditions 2026-04-27
|
2026-04-27 |