Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
400
Countries
1
Sites
1
Schizophrenia
Key facts
- Sponsor
- Syremis Therapeutics 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
- 8 Jun 2026 → ongoing
- Decision date (initial)
- 2026-06-08
- 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
Syremis Therapeutics Ltd.
- Sponsor organisation
- Syremis Therapeutics Ltd.
- Address
- 17 Yegia Kapayim
- City
- Petakh Tikva
- Postcode
- 4913000
- Country
- Israel
Scientific contact point
- Organisation
- Syremis Therapeutics Ltd.
- Contact name
- Head of Clinical Pharmacology
Public contact point
- Organisation
- Syremis Therapeutics Ltd.
- Contact name
- Head of Clinical Pharmacology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 280 | 1 |
| Rest of world
United States
|
— | 120 | — |
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 | 2026-06-08 | 2026-06-10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-06 | France | Acceptable 2026-05-12
|
2026-06-08 |