Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
1
Atopic Dermatitis
Key facts
- Sponsor
- Triveni Bio Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 9 Oct 2025 → ongoing
- Decision date (initial)
- 2025-10-07
- 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
Atopic Dermatitis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Triveni Bio Inc.
- Sponsor organisation
- Triveni Bio Inc.
- Address
- 99 Coolidge Avenue Suite 450
- City
- Watertown
- Postcode
- 02472-2802
- Country
- United States
Scientific contact point
- Organisation
- Triveni Bio Inc.
- Contact name
- Triveni Bio Inc.
Public contact point
- Organisation
- Triveni Bio Inc.
- Contact name
- Triveni Bio Inc.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Dermatology, 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 | 2025-10-09 | 2025-10-21 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-18 | Netherlands | Acceptable 2025-10-07
|
2025-10-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-10 | Netherlands | Acceptable 2025-10-07
|
2025-10-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-21 | Netherlands | Acceptable 2025-10-07
|
2026-01-21 |