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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
JPH034
DrugOral JPH034
Placebo Control
Other interventionSimple Syrup
Treatment groups
40 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 1. SAD Cohort 1 - 20mgExperimental treatment 2 interventions
Group B: 2. SAD Cohort 2 - 40mgExperimental treatment 2 interventions
Group C: 3. SAD Cohort 3 - 80mgExperimental treatment 2 interventions
Group D: 4. SAD Cohort 4 -160mgExperimental treatment 2 interventions
Group E: 5. SAD Cohort 5 - TBDExperimental treatment 2 interventions
Group F: 6. SAD Food Effect - TBDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability of JPH034 - Adverse Events
Frequency and severity of Adverse Events (AEs), including SAEs.
Time frame
From first participant dosed to last participant completion (Day 9) in each cohort .2
Safety and Tolerability of JPH034 - Discontinuation of Study Intervention
Frequency of premature discontinuation of study intervention due to AEs.
Time frame
From first participant dosed to last participant completion (Day 9) in each cohort .3
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.
Time frame
From first participant dosed to last participant completion (Day 9) in each cohort.4
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.
Time frame
From first participant dosed to last participant completion (Day 9) in each cohort.Secondary outcomes
1
To characterize the single dose plasma PK of JPH034 and its metabolite (M1)
Plasma measurement of JPH034 and metabolite (M1).
Time frame
PK sampling pre-dose to 96 hrs postdose for each participant.2
To characterize the single dose urine PK of JPH034 and its metabolite (M1) in cohort 3
Urine measurement of JPH034 and metabolite (M1).
Time frame
Urine sampling pre-dose to 24 hrs postdose for each participant in cohort 3.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov