Clinical trial • Phase I • Gastroenterology
LMT503 for Healthy volunteers
Phase I trial of LMT503 for Healthy volunteers. adaptive. 72 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 28-10-2024
- First CTIS Authorization Date
- 25-11-2024
Trial design
adaptive Phase I trial across 1 site in Netherlands.
- Adaptive
- True, includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts and a food effect evaluation (dose-escalation cohort design)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 72
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 9
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 72
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 25-11-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 72
Sites
- Site Name
- Pharma Bio-Research Group
- Department Name
- Program Management
- Contact Person Name
- Maria Velinova
- Contact Person Email
- Maria.Velinova@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Lmito Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Korea, Republic of
Investigational products
- Investigational Product Name
- LMT503
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