Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
104
Countries
1
Sites
1
BKV-associated nephropathy
Key facts
- Sponsor
- AiCuris Anti-infective Cures AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 2 Oct 2024 → 16 Mar 2026
- Decision date (initial)
- 2024-03-15
- 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
BKV-associated nephropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10047438 | Viral infectious disorders | 10021881 |
| 20.1 | LLT | 10065333 | BK virus nephropathy | 10021881 |
| 20.1 | PT | 10065381 | Polyomavirus-associated nephropathy | 100000004862 |
| 20.0 | HLT | 10057200 | Polyomavirus infections | 10021881 |
| 20.0 | SOC | 10021881 | Infections and infestations | 1 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AiCuris Anti-infective Cures AG
- Sponsor organisation
- AiCuris Anti-infective Cures AG
- Address
- Friedrich-Ebert-Strasse 475, Elberfeld West Elberfeld West
- City
- Wuppertal
- Postcode
- 42117
- Country
- Germany
Scientific contact point
- Organisation
- AiCuris Anti-infective Cures AG
- Contact name
- Dirk Kropeit
Public contact point
- Organisation
- AiCuris Anti-infective Cures AG
- Contact name
- Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 104 | 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 | 2024-10-02 | 2026-03-16 | 2024-10-07 | 2025-11-21 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Germany | Acceptable 2024-03-13
|
2024-03-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-29 | Germany | Acceptable 2024-08-22
|
2024-08-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-29 | Germany | Acceptable 2024-11-25
|
2024-11-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-19 | Germany | Acceptable 2025-01-13
|
2025-01-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-07 | Germany | Acceptable 2025-04-24
|
2025-04-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-08 | Germany | Acceptable 2025-10-08
|
2025-10-10 |