Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
60
Countries
1
Sites
1
Virus diseases
Key facts
- Sponsor
- Pharma Mar S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Jan 2026 → ongoing
- Decision date (initial)
- 2025-03-10
- 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
Virus diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10032621 | Other specified diseases due to viruses | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharma Mar S.A.
- Sponsor organisation
- Pharma Mar S.A.
- Address
- Avenida De Los Reyes 1, Poligono Industrial La Mina Poligono Industrial La Mina
- City
- Colmenar Viejo
- Postcode
- 28770
- Country
- Spain
Scientific contact point
- Organisation
- Pharma Mar S.A.
- Contact name
- Clinical Development Oncology Unit
Public contact point
- Organisation
- Pharma Mar S.A.
- Contact name
- Clinical Development Oncology Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 60 | 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 | 2025-07-01 | 2025-07-14 | 2025-08-08 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-104249
- Halt date
- 2025-08-08
- Member states concerned
- Spain
- Publication date
- 2025-10-30
- Reason
- Sponsor decision
- Explanation
- A participant has experienced an unexpected event in the stage 0 of the trial which was classified as non-serious. Sponsor is revisiting the trial design and assessing if the protocol should be updated or not. Participants enrolment is to be resumed when the assessment is concluded and the protocol changed and approved, in case it would be needed.
- Follow-up measures
- To temporary halt the recruitment to further investigate and assess if the protocol should be updated or not.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-22 | Spain | Acceptable 2025-03-10
|
2025-03-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-08 | Spain | Acceptable 2025-03-10
|
2025-07-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-08 | Spain | Acceptable | 2025-07-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-27 | Spain | Acceptable 2026-01-05
|
2026-01-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-20 | Spain | Acceptable 2026-01-23
|
2026-01-26 |