NCT07534657

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: J-Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and PK and PD of single-ascending doses of JPH034 and its major metabolite (M1) in healthy adult participants. In addition, an unblinded pilot food effect (FE) evaluation is planned to characterize the effect of food (high-fat meal vs fasted conditions) on the single-dose PK of JPH034. Participants will be randomly allocated to treatment cohorts (JPH034 or placebo) at the dose level open at the time of enrollment; randomization (prior to dosing on Day 1) will be managed using a sequential list. Participants will be permitted to participate in only 1 dose cohort of the study. Single-Ascending Dose: The first SAD cohort will receive a dose of 20 mg JPH034 or placebo, and subsequent cohorts will receive anticipated escalating doses of JPH034 or placebo. Sentinel dosing will be utilized for all SAD cohorts. Eligible participants will check into the clinic on Day -1 and will remain confined through the 48-hour PK collection on Day 3. On Day 1, participants will receive a single dose of study intervention under fasted conditions. Following completion of the observation period for the last participant in each cohort, the Safety Review Committee (SRC) will review available data from the observation period (including TEAEs, laboratory results, vital signs, ECGs, and PK data) and any cumulative data from prior cohorts. The observation period will be 7 days after administration of study intervention. The SRC may review unblinded data as necessary. Pilot Food Effect: The FE evaluation will be performed at a safe dose level as determined by the SRC. The effect of food on the systemic exposure of JPH034 is not known; therefore, the SRC will consider safety associated with potentially higher exposures and select an appropriate dose for the FE evaluation accordingly. JPH034-treated participants (N = 6) from the selected SAD cohort will return for a pilot FE evaluation. Participants will undergo a washout prior to this FE evaluation (fasted dose on Day 1; fed dose on FE Day 1) for a minimum of 5 half-lives of JPH034. Participants will check into the clinic on FE Day -1 and will remain confined through the 48-hour PK collection on FE Day 3. On FE Day 1, participants will receive a single dose of JPH034 in a fed state (high-fat/high-calorie standard meal) following a minimum 10-hour overnight fast. Participants will have 30 minutes to ingest the entire meal, and the JPH034 dose will be administered 30 minutes after the start of the meal. Participants will then fast for at least 4 hours postdose. For the SAD and FE cohorts safety assessments, as well as blood samples and urine collection for PK analyses will be performed. Participants will return to the clinic for PK collections 72 and 96 hours after administration of study intervention (Days 4 and 5, respectively). Seven to 9 days after administration of study intervention, participants will attend a follow-up visit.

Conditions

• Health Adult Subjects

Interventions

Type	Name	Description
DRUG	JPH034	Oral JPH034
OTHER	Placebo Control	Simple Syrup

Timeline

• Start date: 2026-03-22
• Primary completion: 2026-10-10
• Completion: 2026-10-10
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study