Clinical trial • Phase I • Cardiology|Neurology
NTR-641 for Acute ischemic stroke
Phase I trial of NTR-641 for Acute ischemic stroke. Randomised, placebo (placebo-controlled arm; dose not specified), adaptive. 72 participants.
Overview
- Trial Therapeutic Area
- Cardiology|Neurology
- Trial Disease
- Acute ischemic stroke
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 05-08-2024
- First CTIS Authorization Date
- 02-12-2024
Trial design
Randomised, placebo (placebo-controlled arm; dose not specified), adaptive Phase I trial across 2 sites in Austria.
- Randomised
- Yes
- Comparator
- Placebo (placebo-controlled arm; dose not specified)
- Adaptive
- True, single-ascending-dose escalation; specific escalation rules not provided.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 72
Eligibility
Recruits 72 Vulnerable populations selected; no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable populations selected; no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 26
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 72
Austria
- Earliest CTIS Part Ii Submission Date
- 04-11-2024
- Latest Decision Or Authorization Date
- 21-03-2025
- Processing Time Days
- 137
- Number Of Sites
- 2
- Number Of Participants
- 72
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Clinical Pharmacology
- Principal Investigator Name
- Bernd Jilma
- Principal Investigator Email
- bernd.jilma@meduniwien.ac.at
- Contact Person Name
- Bernd Jilma
- Contact Person Email
- bernd.jilma@meduniwien.ac.at
- Site Name
- Krankenhaus Der Barmherzigen Brueder Wien
- Department Name
- Abteilung für Neurologie
- Principal Investigator Name
- Julia Ferrari
- Principal Investigator Email
- julia.ferrari@bbwien.ac.at
- Contact Person Name
- Julia Ferrari
- Contact Person Email
- julia.ferrari@bbwien.ac.at
Sponsor
Primary sponsor
- Full Name
- Neutrolis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- NTR-641
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Frequency
- Single-ascending-dose
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