Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Generalized Anxiety Disorder (GAD)
Key facts
- Sponsor
- Newleos Therapeutics Inc.
- 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 Aug 2025 → ongoing
- Decision date (initial)
- 2025-08-06
- 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
Generalized Anxiety Disorder (GAD)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Newleos Therapeutics Inc.
- Sponsor organisation
- Newleos Therapeutics Inc.
- Address
- 501 Boylston Street Floor 10
- City
- Boston
- Postcode
- 02116-3769
- Country
- United States
Scientific contact point
- Organisation
- Newleos Therapeutics Inc.
- Contact name
- Gabriel Jacobs
Public contact point
- Organisation
- Newleos Therapeutics Inc.
- Contact name
- Gabriel Jacobs
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Psychiatry, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-08-08 | 2025-08-21 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-23 | Netherlands | Acceptable 2025-08-06
|
2025-08-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-26 | Netherlands | Acceptable 2025-08-06
|
2025-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-19 | Netherlands | Acceptable | 2025-09-25 |