A Study of JPH034 in Healthy Adult Participants (NCT07534657)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (31 items).
Location: Axis Clinicals Phase 1 Unit — Dilworth, Minnesota
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- History of any active infection within 14 days of dosing with study intervention, if deemed clinically significant by the Investigator and Sponsor.
- Any acute illness within 30 days prior to dosing with study intervention.
- Clinically significant (as determined by the Investigator) abnormal laboratory test results, including, but not limited to, lipase, amylase, alkaline phosphatase, WBC count, or platelets, at Screening and Check-in. Note: Alkaline phosphatase, WBC count, and platelets must be within normal limits at Screening and Check-in.
- Concurrent conditions that could interfere with safety and/or tolerability measurements, as determined by the Investigator or designee.
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of JPH034.
- History (within 2 years prior to the first dose of study intervention) of moderate or severe use disorder for any substance other than caffeine (based on DSM-5 criteria).
- History of a major psychiatric disorder, ongoing suicidal ideations, or endorsement of suicidal ideation or behavior based on the C-SSRS at Screening.
- Reduced sense of taste, as assessed by taste strips at Screening.
- QTcF \> 450 msec for males or \> 470 msec for females observed at Screening or Check-in.
- History or presence of any type of arrhythmia or irregular heartbeat.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Axis Clinicals Phase 1 Unit — Dilworth, Minnesota
📞 Contact the Study Coordinator
Phone: +81-3-6432-4270
Email: yoshitake@j-pharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: 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.
More studies in Health Adult Subjects
Explore by condition: All Health Adult Subjects clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.