Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
76
Countries
1
Sites
1
Type 1 diabetes mellitus (healthy participants)
Key facts
- Sponsor
- Civica Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 6 Jan 2026 → ongoing
- Decision date (initial)
- 2025-12-12
- 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
Type 1 diabetes mellitus (healthy participants)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Civica Inc.
- Sponsor organisation
- Civica Inc.
- Address
- 2912 West Executive Parkway Ste 325
- City
- Lehi
- Postcode
- 84043-4622
- Country
- United States
Scientific contact point
- Organisation
- Civica Inc.
- Contact name
- Brad Bath
Public contact point
- Organisation
- Civica Inc.
- Contact name
- Brad Bath
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 76 | 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 | 2026-01-06 | 2026-01-06 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-15 | Germany | Acceptable 2025-12-11
|
2025-12-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-16 | Germany | Acceptable 2025-12-11
|
2026-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-17 | Germany | Acceptable 2026-05-04
|
2026-05-06 |