A Study of JPH034 in Healthy Adult Participants

NCT07534657 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JPH034-P1-HV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Adult Subjects

Keywords

Single Ascending Dose

Outcome Measures

Primary Outcomes (14)

• Safety and Tolerability of JPH034 - Adverse Events

  Frequency and severity of Adverse Events (AEs), including SAEs.

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

• Safety and Tolerability of JPH034 - Discontinuation of Study Intervention

  Frequency of premature discontinuation of study intervention due to AEs.

  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.

  Clinically significant post dose measures for Chemistry, Hematology and Urinalysis Laboratory tests will be reported using standardized units.

  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.

  Clinically significant post dose measures for Chemistry, Hematology and Urinalysis Laboratory tests will be compared with the respective baseline value and the change will be reported using standardized units of measure.

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

• Safety and Tolerability of JPH034 - Measurement of Heart Rate.

  Clinically significant post dose measures for Heart Rate will be reported in beats/min.

  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.

  Clinically significant post dose measures for heart rate will be compared with the respective baseline value and the change will be reported in beats/min.

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

• Safety and Tolerability of JPH034 - Measurement of blood pressure.

  Clinically significant post dose measures for blood pressure will be reported in mmHg.

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

• Safety and Tolerability of JPH034 - Measurement of change from baseline for blood pressure.

  Clinically significant post dose measures for blood pressure will be compared with the respective baseline value and the change will be reported in mmHg.

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

• Safety and Tolerability of JPH034 - Measurement of respiratory rate.

  Clinically significant post dose measures for respiratory rate will be reported in breaths/min.

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

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

  Clinically significant post dose measures for respiratory rate will be compared with the respective baseline value and the change will be reported in breaths/min.

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

• Safety and Tolerability of JPH034 - Measurement of body temperature.

  Clinically significant post dose measures for body temperature will be reported in degrees centigrade.

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

• Safety and Tolerability of JPH034 - Measurement of change from baseline for body temperature.

  Clinically significant post dose measures for body temperature will be compared with the respective baseline value and the change will be reported in degrees centigrade.

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

• Safety and Tolerability of JPH034 - Measurement of QTc interval on ECG.

  Clinically significant QTc interval measurement on ECG will be reported in msec.

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

• Safety and Tolerability of JPH034 - Measurement of change from baseline in QTc interval on ECG.

  Clinically significant post dose measures for QTc interval measurement on ECG will be compared with the respective baseline value and the change will be reported in msec.

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

Secondary Outcomes (2)

• To characterize the single dose plasma PK of JPH034 and its metabolite (M1)

  PK sampling pre-dose to 96 hrs postdose for each participant.

• To characterize the single dose urine PK of JPH034 and its metabolite (M1) in cohort 3

  Urine sampling pre-dose to 24 hrs postdose for each participant in cohort 3.

Study Arms (6)

1. SAD Cohort 1 - 20mg

EXPERIMENTAL

Single dose N = 6 JPH034: 2 Placebo

Drug: JPH034; Other: Placebo Control

2. SAD Cohort 2 - 40mg

EXPERIMENTAL

Single dose N = 6 JPH034: 2 Placebo

Drug: JPH034; Other: Placebo Control

3. SAD Cohort 3 - 80mg

EXPERIMENTAL

Single dose N = 6 JPH034: 2 Placebo

Drug: JPH034; Other: Placebo Control

4. SAD Cohort 4 -160mg

EXPERIMENTAL

Single dose N = 6 JPH034: 2 Placebo

Drug: JPH034; Other: Placebo Control

5. SAD Cohort 5 - TBD

EXPERIMENTAL

Single dose N = 6 JPH034: 2 Placebo

Drug: JPH034; Other: Placebo Control

6. SAD Food Effect - TBD

EXPERIMENTAL

Single dose N = 6 JPH034: 2 Placebo

Drug: JPH034

Interventions

JPH034 DRUG

Oral JPH034

1. SAD Cohort 1 - 20mg; 2. SAD Cohort 2 - 40mg; 3. SAD Cohort 3 - 80mg; 4. SAD Cohort 4 -160mg; 5. SAD Cohort 5 - TBD; 6. SAD Food Effect - TBD

Placebo Control OTHER

Simple Syrup

1. SAD Cohort 1 - 20mg; 2. SAD Cohort 2 - 40mg; 3. SAD Cohort 3 - 80mg; 4. SAD Cohort 4 -160mg; 5. SAD Cohort 5 - TBD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Refrain from donating sperm and
• Use one of the following forms of contraception:
• Abstinence from heterosexual intercourse or
• Condom if partner is a woman of CBP (defined in Section 10.2.1), plus highly effective method of contraception (listed in Section 10.2.2) if partner is a woman of CBP who is not currently pregnant.
• Willing and able to provide voluntary, written informed consent to participate in the study.
• Able to communicate well with the Investigator and/or study site personnel and to comply with the requirements of the entire study.
• Negative drug/alcohol testing at Screening and Check-in.

You may not qualify if:

• 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.
• Long QT syndrome or a history of cardiac disease.
• Potassium or magnesium outside the normal range at Screening or Check-in (potassium normal range = 3.6-5.2 mEq/L; magnesium normal range = 1.9-2.7 mg/dL).
• Use of any drug known to prolong the QT interval within 4 weeks prior to study.
• ALT or AST \> 1.5 × ULN at Screening or Check-in.

Sponsors & Collaborators

• J-Pharma Co., Ltd.: lead

Study Sites (1)

Axis Clinicals Phase 1 Unit

Dilworth, Minnesota, 56529, United States

RECRUITING

Central Study Contacts

Masuhiro Yoshitake

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 16, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)