Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
54
Countries
1
Sites
1
influenza
Key facts
- Sponsor
- Adamed Pharma S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 13 Nov 2024 → 20 May 2025
- Decision date (initial)
- 2024-10-23
- 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
influenza
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10064097 | Avian influenza | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Adamed Pharma S.A.
- Sponsor organisation
- Adamed Pharma S.A.
- Address
- Ul. Mariana Adamkiewicza 6a, Pienkow Pienkow
- City
- Czosnow
- Postcode
- 05-152
- Country
- Poland
Scientific contact point
- Organisation
- Adamed Pharma S.A.
- Contact name
- Pharmacokinetic Study Team
Public contact point
- Organisation
- Adamed Pharma S.A.
- Contact name
- Pharmacokinetic Study Team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 54 | 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 |
|---|---|---|---|---|---|
| Czechia | 2024-11-13 | 2025-05-20 | 2024-11-13 | 2024-11-29 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-01 | Czechia | Acceptable 2024-10-18
|
2024-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-24 | Czechia | Acceptable 2025-04-02
|
2025-04-02 |