drugset / Trial / NCT07534657

A Study of JPH034 in Healthy Adult Participants

NCT07534657 ↗

Phase 1 Recruiting 40 enrolled J-Pharma Co., Ltd.
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2026-03-22
Primary completion
2026-10-10
Completion
2026-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject JPH034 Unknown 20 mg Oral
Subject JPH034 Unknown 40 mg Oral
Subject JPH034 Unknown 80 mg Oral
Subject JPH034 Unknown 160 mg Oral

Indications

No indication recorded.