Clinical trial • Phase I • Other
M5542 for Healthy volunteer
Phase I trial of M5542 for Healthy volunteer. adaptive. 49 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 29-05-2024
- First CTIS Authorization Date
- 09-08-2024
Trial design
adaptive Phase I trial across 1 site in Germany.
- Adaptive
- True - single ascending dose (dose-escalation) design mentioned; no detailed escalation rules, dose levels, interim analysis or stopping rules provided in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 49
Eligibility
Recruits 49 Vulnerable population not selected; no special consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; no special consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 49
- Recruitment Window Months
- 26
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 49
Germany
- Earliest CTIS Part Ii Submission Date
- 18-07-2024
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 547
- Number Of Sites
- 1
- Number Of Participants
- 49
Sites
- Site Name
- Nuvisan GmbH
- Department Name
- Clinical Services
- Contact Person Name
- Michael Lissy
- Contact Person Email
- michael.lissy@nuvisan.com
- Number Of Participants
- 49
Sponsor
Primary sponsor
- Full Name
- Merck Healthcare KGaA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- M5542
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