NCT07181538

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

16 days

First QC Date

August 29, 2025

Last Update Submit

September 11, 2025

Conditions

Healthy

Keywords

pharmacokinetic

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

JLP-2302 and JP-1366 crossover

EXPERIMENTAL
Drug: JLP-2302Drug: JP-1366

JP-1366 and JLP-2302 crossover

ACTIVE COMPARATOR
Drug: JLP-2302Drug: JP-1366

Interventions

JLP-2302DRUG

taking JLP-2302

JLP-2302 and JP-1366 crossoverJP-1366 and JLP-2302 crossover
JP-1366DRUG

taking JP-1366

JLP-2302 and JP-1366 crossoverJP-1366 and JLP-2302 crossover

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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\*

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yangji Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 18, 2025

Study Start

February 4, 2025

Primary Completion

February 20, 2025

Study Completion

March 5, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)