Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
110
Countries
1
Sites
1
Schizophrenia
Key facts
- Sponsor
- Clexio Biosciences Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 31 Jul 2025 → 23 Dec 2025
- Decision date (initial)
- 2025-07-30
- 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
Schizophrenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10039626 | Schizophrenia | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Clexio Biosciences Ltd.
- Sponsor organisation
- Clexio Biosciences Ltd.
- Address
- Northern High Tech Park, 10 Hakidma 10 Hakidma
- City
- Yokne'am Ilit
- Postcode
- 2069200
- Country
- Israel
Scientific contact point
- Organisation
- Clexio Biosciences Ltd.
- Contact name
- Head of Clinical Pharmacology
Public contact point
- Organisation
- Clexio Biosciences Ltd.
- Contact name
- Head of Clinical Pharmacology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 110 | 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 |
|---|---|---|---|---|---|
| France | 2025-07-31 | 2025-12-23 | 2025-08-06 | 2025-12-18 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-07-31
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- the sponsor is requested to submit a specific SM Part II in order to update its CTA in line with the documentation approved during the Ad Hoc Assessment FR-0000000099 after the submission of this corrective measure.
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-30 | France | Acceptable 2025-07-15
|
2025-07-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-01 | France | Acceptable 2025-08-07
|
2025-08-07 |