Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
64
Countries
1
Sites
1
Auto immune disorders
Key facts
- Sponsor
- PTC Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 30 Dec 2022 → 22 Dec 2023
- Decision date (initial)
- 2022-12-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501986-38-00
- WHO UTN
- U1111-1284-5164
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Auto immune disorders
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061664 | Autoimmune disorder | 100000004870 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
PTC Therapeutics Inc.
- Sponsor organisation
- PTC Therapeutics Inc.
- Address
- 200 Corporate Court
- City
- South Plainfield
- Postcode
- 07080-2449
- Country
- United States
Scientific contact point
- Organisation
- PTC Therapeutics Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- PTC Therapeutics Inc.
- Contact name
- Medical Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-12-30 | 2023-12-22 | 2022-12-30 | 2023-11-10 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-31 | Netherlands | Acceptable with conditions 2022-12-23
|
2022-12-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-01-27 | Netherlands | Acceptable 2023-02-15
|
2023-02-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-07-17 | Netherlands | Acceptable 2023-07-26
|
2023-07-26 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-24 | Netherlands | Acceptable 2023-07-26
|
2023-10-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-08 | Netherlands | Acceptable 2023-07-26
|
2024-01-08 |