Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Phase I study in healthy male volunteers. Intended indication: Duchenne muscular dystrophy and Becker muscular dystrophy
Key facts
- Sponsor
- Santhera Pharmaceuticals (Schweiz) AG, Santhera Pharmaceuticals (Schweiz) AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 5 Jun 2024 → 6 Jul 2024
- Decision date (initial)
- 2024-05-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Phase I study in healthy male volunteers. Intended indication: Duchenne muscular dystrophy and Becker muscular dystrophy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10013801 | Duchenne muscular dystrophy | 100000004850 |
| 20.0 | PT | 10059117 | Becker's muscular dystrophy | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Santhera Pharmaceuticals (Schweiz) AG
- Sponsor organisation
- Santhera Pharmaceuticals (Schweiz) AG
- Address
- Hohenrainstrasse 24
- City
- Pratteln
- Postcode
- 4133
- Country
- Switzerland
Scientific contact point
- Organisation
- Santhera Pharmaceuticals (Schweiz) AG
- Contact name
- Catherine Dutreix
Public contact point
- Organisation
- Santhera Pharmaceuticals (Schweiz) AG
- Contact name
- Santhera General Inquiries
Santhera Pharmaceuticals (Schweiz) AG
- Sponsor organisation
- Santhera Pharmaceuticals (Schweiz) AG
- Address
- Hohenrainstrasse 24
- City
- Pratteln
- Postcode
- 4133
- Country
- Switzerland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 30 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-06-05 | 2024-07-06 | 2024-06-05 | 2024-06-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-14 | Germany | Acceptable 2024-04-30
|
2024-05-06 |