Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
49
Countries
1
Sites
1
Healthy
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 30 Jan 2026 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513069-37-00
- ClinicalTrials.gov
- NCT06577337
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 49 | 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 | 2024-08-21 | 2024-09-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-65974
- Halt date
- 2025-01-03
- Member states concerned
- Germany
- Publication date
- 2025-01-10
- Reason
- Sponsor decision
- Explanation
- To assess new information and the need to make changes to the clinical trial
- Follow-up measures
- Inform Principal Investigator and study participants of Sponsor decision to temporarily halt trial. Recruitment is paused. All remaining follow-up study visits to continue as scheduled
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Germany | Acceptable 2024-08-06
|
2024-08-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-10 | Germany | Acceptable 2026-01-08
|
2026-01-16 |