Status:
COMPLETED
Phase 1 Study of JLP-2302 and JP-1366: PK and Safety in Healthy Volunteers
Lead Sponsor:
Onconic Therapeutics Inc.
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the pharmacokinetics and the safety after administration of "JLP-2302" and "JP-1366" in healthy volunteers.
Eligibility Criteria
Inclusion
- Subjects with a body mass index (BMI) between 18.0 and 30.0 kg/m²
- Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
- Subjects who agree to use a medically acceptable method of contraception\*
Exclusion
- Subjects who have taken enzyme-inducing or -inhibiting drugs
- Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
- Subjects with a history of gastrointestinal surgery that may affect drug absorption
- Subjects with a clinically significant history of psychiatric illness
- Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding
Key Trial Info
Start Date :
February 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT07181538
Start Date
February 4 2025
End Date
March 5 2025
Last Update
September 18 2025
Active Locations (1)
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1
Yangji Hospital
Seoul, South Korea