Phase 1 Study of JLP-2302 and JP-1366: PK and Safety in Healthy Volunteers

Onconic Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JP-1366; Drug: JLP-2302

Study type: Interventional

Funder types: Industry

Identifiers

NCT07181538

JP-1366-110

Details and patient eligibility

About

This study aims to evaluate the pharmacokinetics and the safety after administration of "JLP-2302" and "JP-1366" in healthy volunteers.

Enrollment: 55 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

JLP-2302 and JP-1366 crossover

Experimental group

Treatment:

Drug: JLP-2302

Drug: JP-1366

JP-1366 and JLP-2302 crossover

Active Comparator group

Treatment:

Drug: JLP-2302

Drug: JP-1366