Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
53
Countries
1
Sites
1
CCI
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 17 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
CCI
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10027433 | Metabolism and nutrition disorders | 6 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 53 | 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 | 2025-06-17 | 2025-06-20 | 2026-04-09 |
Application history
5 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 2025-06-04
|
2025-06-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-30 | Belgium | Acceptable with conditions 2025-06-04
|
2025-07-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-25 | Belgium | Acceptable 2025-09-25
|
2025-09-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-10 | Belgium | Acceptable 2025-09-25
|
2025-12-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-22 | Belgium | Acceptable 2026-01-20
|
2026-01-23 |