Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
55
Countries
1
Sites
1
Ulcerative Colitis
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Sep 2024 → 25 Oct 2025
- Decision date (initial)
- 2023-10-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
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 | Ended | 55 | 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 | 2023-11-15 | 2023-11-17 | 2025-09-17 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-14526
- Halt date
- 2024-02-09
- Member states concerned
- Belgium
- Publication date
- 2024-02-21
- Reason
- Sponsor decision
- Explanation
- Pfizer has initiated a temporary halt of the First in Human Study C5471001, stopping further recruitment and dosing of participants. Pfizer’s decision to pause study activities is not due to any safety concern or any safety-related observations of concern from the study to date.
Dosing of Cohort 1, periods 1-3, has been completed and has generated PK profiles that differ from those that were predicted.
All observed exposures were below the PK stopping limits defined in the protocol. - Follow-up measures
- The Sponsor is continuing with the required follow up visits and follow up phone calls for the Cohort 1 participants.
The Sponsor is now investigating and performing additional analysis of the samples collected to date in the study to potentially inform further development.
Depending on the results of these investigations, the Sponsor may propose to continue the study with doses currently specified in the protocol or modify the proposed doses. Alternatively, the Sponsor may decide to terminate the study.
The Sponsor plans to submit a substantial modification, including any necessary updates to study documents, in approximately 8 weeks, if there is intent to restart the clinical trial. If the Sponsor decides to terminate the study an early termination notification will be submitted in accordance with Articles 37 and 38 of the
Clinical Trials Regulation. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-27 | Belgium | Acceptable 2023-10-30
|
2023-10-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-22 | Belgium | Acceptable 2024-08-12
|
2024-08-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-08 | Belgium | Acceptable 2025-05-15
|
2025-05-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-27 | Belgium | Acceptable | 2025-06-27 |