Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
24
Countries
1
Sites
1
Not applicable (trial is a pharmacokinetic study in healthy volunteers). Intended indication: neuroinflammation-related diseases, including Alzheimer’s Disease
Key facts
- Sponsor
- Neurotherapia Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 11 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-19
- 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
Not applicable (trial is a pharmacokinetic study in healthy volunteers). Intended indication: neuroinflammation-related diseases, including Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neurotherapia Inc.
- Sponsor organisation
- Neurotherapia Inc.
- Address
- 1500 Chagrin River Road
- City
- Gates Mills
- Postcode
- 44040-7451
- Country
- United States
Scientific contact point
- Organisation
- Neurotherapia Inc.
- Contact name
- Chief Medical Officer (CMO)
Public contact point
- Organisation
- Neurotherapia Inc.
- Contact name
- Chief Medical Officer (CMO)
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 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 |
|---|---|---|---|---|---|
| Hungary | 2025-12-11 | 2025-12-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-26 | Hungary | Acceptable 2025-11-19
|
2025-11-19 |