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Health Adult SubjectsHealthy volunteersDrugPhase 1

What this study is

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.

What's being tested

  • JPH034

    Intervention · DRUG

    Oral JPH034

  • Placebo Control

    Intervention · OTHER

    Simple Syrup

Study details

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
Sponsor
J-Pharma Co., Ltd.
Conditions
Health Adult Subjects
Enrolling
40 people
Starts
2026-03-22
Est. completion
2026-10-10
Design
Double-blind, randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗