Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
12
Countries
1
Sites
1
Chronic kidney disease
Key facts
- Sponsor
- OPTERION Health AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 16 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-09
- 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
Chronic kidney disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10076411 | Chronic kidney disease stage 4 | 10038359 |
| 28.0 | LLT | 10076412 | Chronic kidney disease stage 5 | 10038359 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
OPTERION Health AG
- Sponsor organisation
- OPTERION Health AG
- Address
- Hofackerstrasse 40b
- City
- Muttenz
- Postcode
- 4132
- Country
- Switzerland
Scientific contact point
- Organisation
- OPTERION Health AG
- Contact name
- Maxim Voropaiev
Public contact point
- Organisation
- OPTERION Health AG
- Contact name
- Maxim Voropaiev
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Latvia | Ongoing, recruitment ended | 12 | 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 |
|---|---|---|---|---|---|
| Latvia | 2026-02-16 | 2026-02-23 | 2026-05-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-10 | Latvia | Acceptable 2026-01-07
|
2026-01-09 |