Actively Recruiting
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single-ascending Doses of JPH034 in Healthy Adults
Led by J-Pharma Co., Ltd. · Updated on 2026-04-16
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes JPH034 in healthy adults aged 18 to 50 years. This Phase 1, randomized, double-blind, placebo-controlled trial aims to identify side effects and understand the effects of food on the drug's absorption. The study includes multiple dose groups with escalating doses and a special evaluation to see how a high-fat meal affects JPH034 levels in the body. Participants will be randomly assigned to receive either JPH034 or a placebo in single-ascending dose (SAD) groups. Each SAD cohort will receive one dose and be observed in a clinic setting from the day before dosing through 48 hours after. After completing the SAD groups, some participants will return for a pilot food effect evaluation, where they will take JPH034 with a high-fat meal to study how food influences the drug's presence in the bloodstream. Participants remain in the clinic for several days during these periods. Throughout the study, participants will undergo physical exams, vital sign checks, ECGs, and safety lab tests to monitor health and detect any side effects. Blood and urine samples are collected to measure how much JPH034 and its main metabolite enter and stay in the body. Follow-up visits occur 7 to 9 days after dosing to assess overall safety. The study involves close monitoring from dosing until the final follow-up visit, lasting about 9 days per participant.
CONDITIONS
Brief Title
A Study of JPH034 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 50 years at screening
- Body mass index (BMI) between 18.5 and 34 kg/m2
- Females must not be pregnant or breastfeeding and agree to use contraception or be permanently infertile
- Females must have negative pregnancy tests at screening and check-in
- Males must agree to refrain from sperm donation and use contraception during the study and for 30 days after
- Able to provide written informed consent
- Able to communicate well with study staff and comply with study requirements
- Negative drug and alcohol tests at screening and check-in
- Vital signs within specified ranges (systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, heart rate >45 to ≤100 bpm)
- Normal kidney function with eGFR > 90 mL/min (or acceptable by investigator judgment)
You will not qualify if you...
- History or presence of significant cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, neurological, or psychiatric disorders
- Recent active infection within 14 days before dosing
- Acute illness within 30 days before dosing
- Abnormal lab test results deemed significant by investigator
- Conditions interfering with safety or drug processing
- History of moderate or severe substance use disorder within 2 years (except caffeine)
- Major psychiatric disorder or suicidal ideation
- Reduced sense of taste
- Abnormal QTc interval or history of arrhythmia or cardiac disease
- Abnormal potassium or magnesium levels
- Use of drugs that prolong QT interval within 4 weeks before study
- Elevated liver enzymes or bilirubin beyond set limits
- Current or chronic liver disease
- Recent use of medications or exposure to investigational agents
- Positive tests for hepatitis B, hepatitis C, HIV, COVID-19, or tuberculosis
- Known allergy to JPH034 or related drugs
- Food allergies or dietary restrictions that prevent study meal ingestion
- Recent blood or plasma donation
- Inability or unwillingness to cooperate with study staff
- Study site employees or conflicts of interest with study staff
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - 5 days
Participants receive a single dose of JPH034 or placebo under fasting conditions and remain confined for PK collection and safety monitoring.
Check-in on Day -1, dosing on Day 1, and confinement through Day 3 with additional PK collections on Days 4 and 5
Duration - 1 visit approximately 7 to 9 days after dosing
Participants attend a follow-up visit 7 to 9 days after dosing for safety assessments.
1 follow-up visit (in-person)
Duration - 5 days
Participants who completed the initial dosing return for a pilot food effect evaluation involving a single dose of JPH034 administered with a high-fat meal, with confinement and PK collection similar to the initial treatment period.
Check-in on FE Day -1, dosing on FE Day 1, and confinement through FE Day 3 with additional PK collections on Days 4 and 5
Duration - 1 visit approximately 7 to 9 days after dosing
Participants in the food effect evaluation attend a follow-up visit 7 to 9 days after dosing for safety assessments.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Axis Clinicals Phase 1 Unit
Dilworth, Minnesota, United States, 56529
Actively Recruiting
Research Team
M
Masuhiro Yoshitake
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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