Clinical trial • Phase I • Respiratory
RCS-21 for Healthy volunteers
Phase I trial of RCS-21 for Healthy volunteers. None/Not specified-controlled, adaptive. 24 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-08-2024
- First CTIS Authorization Date
- 08-11-2024
Trial design
None/Not specified-controlled, adaptive Phase I trial across 1 site in Germany.
- Comparator
- None/Not specified
- Adaptive
- True (single-ascending dose escalation design specified)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 24
Eligibility
Recruits 24 No vulnerable populations selected (isVulnerablePopulationSelected: false).
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false)
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 20
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Germany
- Earliest CTIS Part Ii Submission Date
- 28-10-2024
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 553
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
- Department Name
- Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
- Contact Person Name
- Jens Hohlfeld
- Contact Person Email
- jens.hohlfeld@item.fraunhofer.de
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Rnatics GmbH
- Organisation Type
- Industry
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- RCS-21
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