A Study of JPH034 in Healthy Adult Participants
ConditionHealth Adult Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorJ-Pharma Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JPH034
- Placebo Control
Treatment groups
40 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov