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RECRUITING
NCT07534657
PHASE1

A Study of JPH034 in Healthy Adult Participants

Sponsor: J-Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the safety, tolerability, and PK of JPH034 and identify side effects that occur in healthy participants between the ages of 18 and 50 years. Participants enrolling in the trial will be randomly assigned to receive JPH034 or placebo. Participants in the in single-ascending dose (SAD) cohorts will receive treatment once, and one group of participants will receive treatment a second time to study the effects of food. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety. Blood tests will be performed to measure how much JPH034 and its major metabolite (M1) gets into the bloodstream and how long it stays in the body.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-ascending Doses of JPH034 in Healthy Adult Male and Female Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-22

Completion Date

2026-10-10

Last Updated

2026-08-06

Healthy Volunteers

Yes

Interventions

DRUG

JPH034

Oral JPH034

OTHER

Placebo Control

Simple Syrup

Locations (1)

Axis Clinicals Phase 1 Unit

Dilworth, Minnesota, United States