Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Authorised, recruitment pending
Participants planned
44
Countries
1
Sites
1
treatment of myasthenia gravis
Key facts
- Sponsor
- Vianex S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-06-02
- 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
treatment of myasthenia gravis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028417 | Myasthenia gravis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vianex S.A.
- Sponsor organisation
- Vianex S.A.
- Address
- Varibobi Street 8
- City
- Kifisia
- Postcode
- 146 71
- Country
- Greece
Scientific contact point
- Organisation
- Vianex S.A.
- Contact name
- George Florakis
Public contact point
- Organisation
- Vianex S.A.
- Contact name
- George Florakis
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 44 | 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 | 2026-05-06 | Czechia | Acceptable 2026-05-26
|
2026-06-02 |