Clinical trial • Phase I • Neurology
VNA-318 for Cognitive impairment
Phase I trial of VNA-318 for Cognitive impairment. Randomised, placebo (dose/schedule not specified)-controlled. 96 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Cognitive impairment
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 23-04-2024
- First CTIS Authorization Date
- 02-08-2024
Trial design
Randomised, placebo (dose/schedule not specified)-controlled Phase I trial across 1 site in France.
- Randomised
- Yes
- Comparator
- placebo (dose/schedule not specified)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 96
Eligibility
Recruits 96 No vulnerable population selected; population = Healthy volunteers (male only). No information on consent or assent handling provided in the record..
- Vulnerable Population
- No vulnerable population selected; population = Healthy volunteers (male only). No information on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 96
- Recruitment Window Months
- 8
- Consent Approach
- No information on informed consent or assent provided in the record; population are healthy adult male volunteers and no vulnerable populations selected.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 96
France
- Earliest CTIS Part Ii Submission Date
- 23-04-2024
- Latest Decision Or Authorization Date
- 02-08-2024
- Processing Time Days
- 101
- Number Of Sites
- 1
- Number Of Participants
- 96
Sites
- Site Name
- Biotrial
- Department Name
- Unité Clinique
- Contact Person Name
- Marina Klein
- Contact Person Email
- marina.klein@biotrial.com
Sponsor
Primary sponsor
- Full Name
- Vandria SA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- VNA-318
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