RecruitingPhase 1NCT07534657

A Study of JPH034 in Healthy Adult Participants

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


Sponsor

J-Pharma Co., Ltd.

Enrollment

40 participants

Start Date

Mar 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called JPH034 and Placebo Control for people with health adult subjects. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJPH034

Oral JPH034

OTHERPlacebo Control

Simple Syrup


Locations(1)

Axis Clinicals Phase 1 Unit

Dilworth, Minnesota, United States

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NCT07534657


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