Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
24
Countries
1
Sites
1
Phase I study in healthy male and female volunteers. Intended indication: mood disorders
Key facts
- Sponsor
- Protagenic Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 1 Aug 2025 → 24 Sep 2025
- Decision date (initial)
- 2025-07-02
- 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
Phase I study in healthy male and female volunteers. Intended indication: mood disorders
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10057666 | Anxiety disorder | 100000004873 |
| 21.1 | PT | 10036316 | Post-traumatic stress disorder | 100000004873 |
| 20.1 | LLT | 10079614 | Mood disorder | 10037175 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Protagenic Therapeutics Inc.
- Sponsor organisation
- Protagenic Therapeutics Inc.
- Address
- 149 5th Avenue Suite 500
- City
- New York
- Postcode
- 10010-6826
- Country
- United States
Scientific contact point
- Organisation
- Protagenic Therapeutics Inc.
- Contact name
- Andrew Slee
Public contact point
- Organisation
- Protagenic Therapeutics Inc.
- Contact name
- Andrew Slee
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 24 | 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 |
|---|---|---|---|---|---|
| Germany | 2025-08-01 | 2025-09-24 | 2025-08-01 | 2025-08-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-29 | Germany | Acceptable 2025-07-01
|
2025-07-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-15 | Germany | Acceptable | 2025-07-24 |