Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
45
Countries
1
Sites
1
Acromegalia
Key facts
- Sponsor
- Universitaetsklinikum Heidelberg AöR
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 11 Jul 2023 → 1 Apr 2025
- Decision date (initial)
- 2024-08-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514225-30-00
- EudraCT number
- 2022-003790-38
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acromegalia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Heidelberg AöR
- Sponsor organisation
- Universitaetsklinikum Heidelberg AöR
- Address
- Im Neuenheimer Feld 672, Neuenheim Neuenheim
- City
- Heidelberg
- Postcode
- 69120
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Heidelberg AöR
- Contact name
- Prof Dr med Antje Blank
Public contact point
- Organisation
- Universitaetsklinikum Heidelberg AöR
- Contact name
- Prof Dr med Antje Blank
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 45 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Internal Medicine IX - Department of clinical pharmacology and pharmacoepidemiology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
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 | 2023-07-11 | 2025-04-01 | 2024-05-23 | 2025-03-31 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-16 | Germany | Acceptable 2024-08-20
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-08 | Germany | Acceptable 2025-02-07
|
2025-02-12 |