A Study of JPH034 in Healthy Adult Participants

Part of paid clinical trials in Dilworth, Minnesota.

Sponsor
J-Pharma Co., Ltd.
Study ID
NCT07534657
Phase
PHASE1
Status
Recruiting
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Conditions

  • Health Adult Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • JPH034 — DRUG
    Oral JPH034
  • Placebo Control — OTHER
    Simple Syrup

Study Details

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.

Key Dates

Start date
Mar 22, 2026
Status verified
Apr 2026
Primary completion
Oct 10, 2026
Completion
Oct 10, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. SAD Cohort 1 - 20mg
    Single dose N = 6 JPH034: 2 Placebo
  • Experimental: 2. SAD Cohort 2 - 40mg
    Single dose N = 6 JPH034: 2 Placebo
  • Experimental: 3. SAD Cohort 3 - 80mg
    Single dose N = 6 JPH034: 2 Placebo
  • Experimental: 4. SAD Cohort 4 -160mg
    Single dose N = 6 JPH034: 2 Placebo
  • Experimental: 5. SAD Cohort 5 - TBD
    Single dose N = 6 JPH034: 2 Placebo
  • Experimental: 6. SAD Food Effect - TBD
    Single dose N = 6 JPH034: 2 Placebo

Primary Outcome Measure

Safety and Tolerability of JPH034 - Adverse Events [ Time Frame: From first participant dosed to last participant completion (Day 9) in each cohort . ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Axis Clinicals Phase 1 UnitDilworthMinnesota56529-

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Axis Clinicals Phase 1 Unit· Dilworth, MN

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