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
J-Pharma Co., Ltd.
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.
Description
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and PK and PD of single-ascending doses of JPH034 and its major metabolite (M1) in healthy adult participants. In addition, an unblinded pilot food effect (FE) evaluation is planned to characterize the effect of food (high-fat meal vs fasted conditions) on the single-dose PK of JPH034. Participants will be randomly allocated to treatment cohorts (JPH034 or placebo) at the dose level open at the time of enrollment; randomization (prior to dosing on Day 1) will be man…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age 18 to 50 years, inclusive, at the time of Screening. 2. Body mass index (BMI) ≥ 18.5 and ≤ 34 kg/m2 at Screening and Check-in. Sex and Contraceptive/Barrier Requirements 3. 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: 1. Postmenopausal (no menses for 12 months, without an alternative medical cause; Section 10.2.1), or 2. Permanent infertility (documented hysterectomy, bilat…
Interventions
- DrugJPH034
Oral JPH034
- OtherPlacebo Control
Simple Syrup
Location
- Axis Clinicals Phase 1 UnitDilworth, Minnesota