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A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
Sponsor: GEn1E Lifesciences
Summary
The goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. The main questions it aims to answer are: \- How does Gen-1124 interact with a human body? Researchers will look at how Gen-1124 interacts with the body and what side effects it may cause. Participants will: * Take Gen-1124 for a single dose * Remain in clinic for 2 days for checkups and tests * Recieve a phone call for a checkup 3 and 7 days after the single dose
Official title: A Phase 1, Single Dose, Open-label Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2025-10-29
Completion Date
2025-12
Last Updated
2025-12-12
Healthy Volunteers
Yes
Conditions
Interventions
GEn-1124
GEn-1124 will be administered to one single dose group of subjects dosed under fed (standardized meal) conditions. GEn-1124 will be administered as an oral capsule formulation containing GEn-1124.
Locations (1)
New Zealand Clinical Research (NZCR)
Christchurch, New Zealand