Actively Recruiting
A Study of JPH034 in Healthy Adult Participants
Led by J-Pharma Co., Ltd. · Updated on 2026-04-16
40
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of JPH034 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years, inclusive, at the time of Screening.
- Body mass index (BMI) between 18.5 and 34 kg/m2 at Screening and Check-in.
- Females must not be pregnant or breastfeeding and agree to avoid egg donation during the study and 30 days after last dose.
- Females must be postmenopausal, permanently infertile, or agree to use effective contraception during the study and 30 days after last dose.
- Females must have negative pregnancy tests at Screening and Check-in.
- Males must agree to refrain from donating sperm and use contraception or abstain from heterosexual intercourse during the study and 30 days after last dose.
- willing and able to provide written informed consent.
- Able to communicate and comply with study requirements.
- Negative drug and alcohol tests at Screening and Check-in.
- Vital signs within specified ranges at Screening and Check-in without clinical significance.
- Normal kidney function defined as eGFR greater than 90 mL/min at Screening, with exceptions allowed based on clinical judgment.
You will not qualify if you...
- History or presence of significant cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, neurological, or psychiatric disorders affecting drug metabolism or study safety.
- Active infection within 14 days before dosing if clinically significant.
- Any acute illness within 30 days before dosing.
- Clinically significant abnormal lab tests at Screening and Check-in.
- Conditions interfering with safety or tolerability measurements.
- Surgical or medical conditions interfering with drug absorption or metabolism.
- History of moderate or severe substance use disorder (except caffeine) within 2 years before dosing.
- Major psychiatric disorders or suicidal ideation.
- Reduced sense of taste.
- QTc interval above 450 msec for males or 470 msec for females.
- History or presence of arrhythmia or cardiac disease.
- Abnormal potassium or magnesium levels at Screening or Check-in.
- Use of drugs prolonging QT interval within 4 weeks before study.
- Elevated liver enzymes or bilirubin above defined levels.
- Current or chronic liver disease.
- Use of prescription or non-prescription medications within 14 days or 5 half-lives before dosing.
- Exposure to investigational agents within 5 half-lives or 30 days before Screening.
- Positive tests for hepatitis C, HIV, or hepatitis B infection.
- Positive COVID-19 test.
- Positive or indeterminate tuberculosis test.
- Known allergy to JPH034 or related drugs.
- Food allergies or dietary restrictions contraindicating participation.
- Unable to ingest an entire high-fat, high-calorie meal.
- Recent blood or plasma donation within specified timeframes.
- Unable or unwilling to cooperate with study staff.
- Study site employees or relatives or anyone causing conflict of interest.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Axis Clinicals Phase 1 Unit
Dilworth, Minnesota, United States, 56529
Actively Recruiting
Research Team
M
Masuhiro Yoshitake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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