Clinical trial • Phase I • Other
MJK2134025 for Stroke
Phase I trial of MJK2134025 for Stroke. Randomised, placebo (dose/schedule not specified)-controlled, adaptive. 70 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Stroke
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 16-01-2025
- First CTIS Authorization Date
- 18-03-2025
Trial design
Randomised, placebo (dose/schedule not specified)-controlled, adaptive Phase I trial across 1 site in Germany.
- Randomised
- Yes
- Comparator
- Placebo (dose/schedule not specified)
- Adaptive
- True, dose-escalation design with single-ascending dose cohorts and multiple intravenous dose cohorts; no further adaptive rules, interim analyses, or stopping rules provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 70
Eligibility
Recruits 70 No vulnerable population selected. Trial population: Healthy volunteers. No consent or assent handling details provided..
- Vulnerable Population
- No vulnerable population selected. Trial population: Healthy volunteers. No consent or assent handling details provided.
Recruitment
- Planned Sample Size
- 70
- Recruitment Window Months
- 21
- Consent Approach
- No informed consent or assent process details provided in the record; trial population is healthy volunteers and no vulnerable population selected.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 70
Germany
- Earliest CTIS Part Ii Submission Date
- 03-03-2025
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 434
- Number Of Sites
- 1
- Number Of Participants
- 70
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Department of Neurology
- Contact Person Name
- Timo Uphaus
- Contact Person Email
- timo.uphaus@unimedizin-mainz.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- MJK2134025
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- First In Human
- Yes
- Frequency
- Single-ascending dose cohorts and multiple intravenous doses (schedule not specified)
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