Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
24
Countries
1
Sites
1
Safety, tolerability and pharmacokinetics of single-ascending doses of RCS-21 in healthy volunteers (AMIR-21)
Key facts
- Sponsor
- Rnatics GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 10 Dec 2024 → ongoing
- Decision date (initial)
- 2024-11-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512351-21-00
- ClinicalTrials.gov
- NCT06752122
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Safety, tolerability and pharmacokinetics of single-ascending doses of RCS-21 in healthy volunteers (AMIR-21)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rnatics GmbH
- Sponsor organisation
- Rnatics GmbH
- Address
- Am Klopferspitz 19a, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- Rnatics GmbH
- Contact name
- Dr. Christina Beck
Public contact point
- Organisation
- Rnatics GmbH
- Contact name
- Dr. Christina Beck
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 24 | 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 | 2024-12-10 | 2025-01-28 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | Germany | Acceptable 2024-11-07
|
2024-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-30 | Germany | Acceptable 2025-02-18
|
2025-02-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-23 | Germany | Acceptable 2025-10-09
|
2025-10-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-10-29 | Germany | Acceptable 2025-10-09
|
2025-10-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-05-04 | Germany | Acceptable 2025-10-09
|
2026-05-04 |