Phase 1 Study of JLP-2302 and JP-1366: PK and Safety in Healthy Volunteers
- Registration Number
- NCT07181538
- Lead Sponsor
- Onconic Therapeutics Inc.
- Brief Summary
This study aims to evaluate the pharmacokinetics and the safety after administration of "JLP-2302" and "JP-1366" in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description JLP-2302 and JP-1366 crossover JLP-2302 - JLP-2302 and JP-1366 crossover JP-1366 - JP-1366 and JLP-2302 crossover JLP-2302 - JP-1366 and JLP-2302 crossover JP-1366 -
- Primary Outcome Measures
Name Time Method Area under the plasma drug concentration-time curve(AUCt) Pre-dose on Day 1 and on Days 2 post-dose Peak Plasma Concentration (Cmax) Pre-dose on Day 1 and on Days 2 post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yangji Hospital
🇰🇷Seoul, South Korea
Yangji Hospital🇰🇷Seoul, South Korea