Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
120
Countries
1
Sites
1
Inflammatory diseases
Key facts
- Sponsor
- Forward Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 31 Mar 2025 → 24 Feb 2026
- Decision date (initial)
- 2025-03-06
- 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
Inflammatory diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10003815 | Autoimmune disorder NOS | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Forward Therapeutics Inc.
- Sponsor organisation
- Forward Therapeutics Inc.
- Address
- 11029 Legacy Boulevard
- City
- Palm Beach Gardens
- Postcode
- 33410-3619
- Country
- United States
Scientific contact point
- Organisation
- Forward Therapeutics Inc.
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- Forward Therapeutics Inc.
- Contact name
- Clinical trial information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 120 | 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 | 2025-03-31 | 2026-02-24 | 2025-03-31 | 2026-01-30 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Germany | Acceptable 2025-03-05
|
2025-03-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-28 | Germany | Acceptable 2025-11-17
|
2025-11-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-18 | Germany | Acceptable 2025-11-17
|
2025-12-18 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-19 | Germany | Acceptable 2025-11-17
|
2026-02-19 |