Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
rheumatoid arthritis
Key facts
- Sponsor
- Generos Biopharma Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2023-11-20
- 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
rheumatoid arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Generos Biopharma Ltd.
- Sponsor organisation
- Generos Biopharma Ltd.
- Address
- Mary Street 122, P. O. Box 31493 P. O. Box 31493
- City
- George Town
- Postcode
- KY1-1206
- Country
- Cayman Islands
Scientific contact point
- Organisation
- Generos Biopharma Ltd.
- Contact name
- Xinyu Liu
Public contact point
- Organisation
- Generos Biopharma Ltd.
- Contact name
- Xinyu Liu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-29 | Bulgaria | Acceptable 2023-11-14
|
2023-11-20 |