RecruitingPhase 1

A Study of JPH034 in Healthy Adult Participants

United States40 participantsStarted 2026-03-22

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 to 50 years, inclusive, at the time of Screening.
✓. Body mass index (BMI) ≥ 18.5 and ≤ 34 kg/m2 at Screening and Check-in. Sex and Contraceptive/Barrier Requirements
✓. Females who are not pregnant or breastfeeding, agree to refrain from donating eggs during the study intervention period and for at least 30 days after the last dose of study intervention, and who meet one of the following conditions:
✓. Postmenopausal (no menses for 12 months, without an alternative medical cause; Section 10.2.1), or
✓. Permanent infertility (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or
✓. Agree to abstain from heterosexual intercourse or to use a highly effective method of contraception (listed in Section 10.2.2) during the study intervention period and for at least 30 days after the last dose of study intervention.
✓. Females with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Check-in (within 24 hours before the first dose of study intervention).
✓. Males who agree to the following conditions during the study intervention period and for at least 30 days after the last dose of study intervention:

Exclusion criteria

What they're measuring

Safety and Tolerability of JPH034 - Adverse Events

Timeframe: From first participant dosed to last participant completion (Day 9) in each cohort .

Safety and Tolerability of JPH034 - Discontinuation of Study Intervention

Timeframe: From first participant dosed to last participant completion (Day 9) in each cohort .

Safety and Tolerability of JPH034 - Measurement of Clinical Safety (Chemistry, Hematology and Urinalysis) Laboratory Tests.

Timeframe: From first participant dosed to last participant completion (Day 9) in each cohort.

Safety and Tolerability of JPH034 - Measurement of the change from baseline of Clinical Safety (Chemistry, Hematology and Urinalysis) Laboratory Tests.

Timeframe: From first participant dosed to last participant completion (Day 9) in each cohort.

Safety and Tolerability of JPH034 - Measurement of Heart Rate.

Timeframe: From first participant dosed to last participant completion (Day 9) in each cohort.

Safety and Tolerability of JPH034 - Measurement of change from baseline for heart rate.

Timeframe: From first participant dosed to last participant completion (Day 9) in each cohort.

Trial details

NCT IDNCT07534657

SponsorJ-Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-10

Contact for this trial

Masuhiro Yoshitake

+81-3-6432-4270 yoshitake@j-pharma.com

View on ClinicalTrials.gov More Health Adult Subjects trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 to 50 years, inclusive, at the time of Screening.
✓. Body mass index (BMI) ≥ 18.5 and ≤ 34 kg/m2 at Screening and Check-in. Sex and Contraceptive/Barrier Requirements
✓. Females who are not pregnant or breastfeeding, agree to refrain from donating eggs during the study intervention period and for at least 30 days after the last dose of study intervention, and who meet one of the following conditions:
✓. Postmenopausal (no menses for 12 months, without an alternative medical cause; Section 10.2.1), or
✓. Permanent infertility (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or
✓. Agree to abstain from heterosexual intercourse or to use a highly effective method of contraception (listed in Section 10.2.2) during the study intervention period and for at least 30 days after the last dose of study intervention.
✓. Females with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Check-in (within 24 hours before the first dose of study intervention).
✓. Males who agree to the following conditions during the study intervention period and for at least 30 days after the last dose of study intervention: