Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Hematologic malignancies
Key facts
- Sponsor
- Curis Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 14 Mar 2024 → 11 May 2024
- Decision date (initial)
- 2024-03-04
- 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
Hematologic malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10003817 | Blood autoimmune disorders | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Curis Inc.
- Sponsor organisation
- Curis Inc.
- Address
- 128 Spring Street Suite 500 Building C
- City
- Lexington
- Postcode
- 02421-7800
- Country
- United States
Scientific contact point
- Organisation
- Curis Inc.
- Contact name
- Sr Medical Director, Clinical Development
Public contact point
- Organisation
- Curis Inc.
- Contact name
- Medical Affairs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 14 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Early Clinical Services, 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 | 2024-03-14 | 2024-05-11 | 2024-03-18 | 2024-03-29 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Netherlands | Acceptable 2024-03-04
|
2024-03-04 |