Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
32
Countries
1
Sites
1
Autoimmune Diseases (Healthy Volunteers)
Key facts
- Sponsor
- T7 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
- 16 Sep 2025 → ongoing
- Decision date (initial)
- 2025-05-27
- 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
Autoimmune Diseases (Healthy Volunteers)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
| 23.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
T7 Therapeutics Inc.
- Sponsor organisation
- T7 Therapeutics Inc.
- Address
- 251 Little Falls Drive
- City
- Wilmington
- Postcode
- 19808-1674
- Country
- United States
Scientific contact point
- Organisation
- T7 Therapeutics Inc.
- Contact name
- Caroline Fortier
Public contact point
- Organisation
- T7 Therapeutics Inc.
- Contact name
- Caroline Fortier
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Temporarily halted | 32 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Semmelweis University
Internal Medicine and Oncology, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
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 | 2025-09-16 | 2025-09-16 | 2025-09-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-101922
- Halt date
- 2025-09-30
- Member states concerned
- Hungary
- Publication date
- 2025-10-14
- Reason
- Sponsor decision
- Explanation
- A protocol amendment is required to integrate key biomarkers and secondary endpoints. As of the date of the temporary suspension, six participants were in the screening period; however, none had received the study drug.
- Follow-up measures
- A protocol amendment will be submitted as promptly as possible to resume screening and enrollment activities.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-27 | Hungary | Acceptable 2025-05-23
|
2025-05-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-26 | Hungary | Acceptable | 2025-09-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-01 | Hungary | Acceptable | 2025-10-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-06 | Hungary | Acceptable 2026-03-25
|
2026-04-29 |