Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
12
Countries
1
Sites
1
Human Immunodeficiency Virus (HIV)
Key facts
- Sponsor
- Consorcio Centro De Investigacion Biomedica En Red
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 20 May 2026 → 21 May 2026
- Decision date (initial)
- 2025-01-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-520529-19-00
- EudraCT number
- 2021-003868-27
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Human Immunodeficiency Virus (HIV)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10020161 | HIV infection | 100000004862 |
| 20.0 | SOC | 10021881 | Infections and infestations | 1 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorcio Centro De Investigacion Biomedica En Red
- Sponsor organisation
- Consorcio Centro De Investigacion Biomedica En Red
- Address
- Pab 11, Avenida De Monforte De Lemos 3-5 Avenida De Monforte De Lemos 3-5
- City
- Madrid
- Postcode
- 28029
- Country
- Spain
Scientific contact point
- Organisation
- Consorcio Centro De Investigacion Biomedica En Red
- Contact name
- Dr. Josep Mallolas
Public contact point
- Organisation
- Consorcio Centro De Investigacion Biomedica En Red
- Contact name
- Dr. Josep Mallolas
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 12 | 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 |
|---|---|---|---|---|---|
| Spain | 2026-05-20 | 2026-05-21 | 2026-05-20 | 2026-05-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | Spain | Acceptable 2025-01-15
|
2025-01-16 |