Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
56
Countries
1
Sites
1
NASH
Key facts
- Sponsor
- Allysta Pharmaceuticals Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2025-10-10
- 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
NASH
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | LLT | 10086372 | NASH | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Allysta Pharmaceuticals Inc.
- Sponsor organisation
- Allysta Pharmaceuticals Inc.
- Address
- 500 108th Avenue Northeast Suite 1100
- City
- Bellevue
- Postcode
- 98004-5535
- Country
- United States
Scientific contact point
- Organisation
- Allysta Pharmaceuticals Inc.
- Contact name
- Henry Hsu
Public contact point
- Organisation
- Allysta Pharmaceuticals Inc.
- Contact name
- Henry Hsu
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 56 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-09 | Bulgaria | Acceptable 2025-10-09
|
2025-10-10 |