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Completed

NCT Number: NCT07181538

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

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

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JLP-2302

Drug

taking JLP-2302

JP-1366

Drug

taking JP-1366

Primary outcomes

  1. Area under the plasma drug concentration-time curve(AUCt)

    Time frame: Pre-dose on Day 1 and on Days 2 post-dose

  2. Peak Plasma Concentration (Cmax)

    Time frame: Pre-dose on Day 1 and on Days 2 post-dose

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "JLP-2302" and "JP-1366" in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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