Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
52
Countries
1
Sites
1
Healthy Volunteers
Key facts
- Sponsor
- SciRhom GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 8 Oct 2024 → 14 May 2025
- Decision date (initial)
- 2024-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507753-15-00
- WHO UTN
- U1111-1296-7580
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy Volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
SciRhom GmbH
- Sponsor organisation
- SciRhom GmbH
- Address
- Am Klopferspitz 19, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- SciRhom GmbH
- Contact name
- Scientific contact point
Public contact point
- Organisation
- SciRhom GmbH
- Contact name
- Scientific contact point
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 52 | 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 |
|---|---|---|---|---|---|
| Austria | 2024-10-08 | 2024-10-08 | 2024-12-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-62704
- Halt date
- 2024-12-09
- Member states concerned
- Austria
- Publication date
- 2024-12-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The temporary halt is a recruitment stop. Participants who are in the study are subject to follow-up examinations according to the protocol.
- Follow-up measures
- Follow-up examinations according to the protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-08 | Austria | Acceptable with conditions 2024-03-04
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-23 | Austria | Acceptable with conditions 2024-11-11
|
2024-11-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-29 | Austria | Acceptable with conditions 2024-11-11
|
2024-11-29 |