Health Adult SubjectsPhase 1NCT07534657
A Study of JPH034 in Healthy Adult Participants
A Phase 1 study testing JPH034 in people with Health Adult Subjects, run by J-Pharma Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- JPH034
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2026to 10 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 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:
- 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
- Agree to abstain from heterosexual intercourse or to use a highly effective method of contraception (listed in Section 10.2.2) during the study intervention period and for at least 30 days after the last dose of study intervention.
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- Females with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Check-in (within 24 hours before the first dose of study intervention).
- Males who agree to the following conditions during the study intervention period and for at least 30 days after the last dose of study intervention:
- Refrain from donating sperm and
- Use one of the following forms of contraception:
- Abstinence from heterosexual intercourse or
- Condom if partner is a woman of CBP (defined in Section 10.2.1), plus highly effective method of contraception (listed in Section 10.2.2) if partner is a woman of CBP who is not currently pregnant.
- Willing and able to provide voluntary, written informed consent to participate in the study.
- Able to communicate well with the Investigator and/or study site personnel and to comply with the requirements of the entire study.
- Negative drug/alcohol testing at Screening and Check-in.
- Vital signs (after semi-recumbent for at least 5 minutes) that are within the following ranges at Screening and Check-in. If not within the stated ranges, they must be without clinical significance as determined by the Investigator.
- Systolic BP, 90 to 140 mmHg, inclusive
- Diastolic BP, 50 to 90 mmHg, inclusive
- Heart rate (HR), > 45 to ≤ 100 bpm
- Normal renal function, defined as eGFR > 90 mL/min at Screening; an Investigator can determine based on clinical judgment whether a lower rate can be accepted based on the muscle composition of the participants.
Who cannot join
- 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.
- Concurrent conditions that could interfere with safety and/or tolerability measurements, as determined by the Investigator or designee.
- Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of JPH034.
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- History (within 2 years prior to the first dose of study intervention) of moderate or severe use disorder for any substance other than caffeine (based on DSM-5 criteria).
- History of a major psychiatric disorder, ongoing suicidal ideations, or endorsement of suicidal ideation or behavior based on the C-SSRS at Screening.
- Reduced sense of taste, as assessed by taste strips at Screening.
- QTcF > 450 msec for males or > 470 msec for females observed at Screening or Check-in.
- History or presence of any type of arrhythmia or irregular heartbeat.
- Long QT syndrome or a history of cardiac disease.
- Potassium or magnesium outside the normal range at Screening or Check-in (potassium normal range = 3.6-5.2 mEq/L; magnesium normal range = 1.9-2.7 mg/dL).
- Use of any drug known to prolong the QT interval within 4 weeks prior to study.
- ALT or AST > 1.5 × ULN at Screening or Check-in.
- Total bilirubin > 1.5 × ULN at Screening or Check-in. For participants with known Gilbert's syndrome these criteria only apply if total bilirubin > 1.5 × ULN as long as direct bilirubin is ≤ 1.5 × ULN.
- Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, steatotic liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the Investigator.
- Use of prescription or non-prescription medications within 14 days or 5 half-lives, whichever is longer, before the first dose of study intervention.
- Exposure to any investigational agent within 5 half-lives or 30 days, whichever is longer, prior to Screening.
- Diagnosis of or positive Screening result for HCVAb, or HIV-1 or HIV-2.
- Diagnosis of or positive Screening result for current or previous natural hepatitis B infection. Results indicative of vaccine-induced immunity (negative HBsAg and HBcAb plus positive HBsAb) will not be exclusionary.
- Positive COVID-19 test.
- Positive or indeterminate IGRA (QuantiFERON®-TB Gold Plus [QFT-Plus]) TB test.
- Known history of allergy to JPH034 or other related drugs or their components.
- Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator or designee, could contraindicate the participant's participation in the study.
- Unable to ingest an entire high-fat/high-calorie meal.
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
- Plasma donation within 7 days of Screening.
- Unable or unwilling to cooperate with site staff for any reason.
- Study site employees, immediate family members of a study site employee, or anyone whose participation in the study would create a conflict of interest for a study site employee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Axis Clinicals Phase 1 Unit
Dilworth, Minnesota, 56529
About this study
Official title: 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
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.
Read the detailed 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 managed using a sequential list. Participants will be permitted to participate in only 1 dose cohort of the study.
Single-Ascending Dose: The first SAD cohort will receive a dose of 20 mg JPH034 or placebo, and subsequent cohorts will receive anticipated escalating doses of JPH034 or placebo. Sentinel dosing will be utilized for all SAD cohorts. Eligible participants will check into the clinic on Day -1 and will remain confined through the 48-hour PK collection on Day 3. On Day 1, participants will receive a single dose of study intervention under fasted conditions.
Following completion of the observation period for the last participant in each cohort, the Safety Review Committee (SRC) will review available data from the observation period (including TEAEs, laboratory results, vital signs, ECGs, and PK data) and any cumulative data from prior cohorts. The observation period will be 7 days after administration of study intervention. The SRC may review unblinded data as necessary.
Pilot Food Effect: The FE evaluation will be performed at a safe dose level as determined by the SRC. The effect of food on the systemic exposure of JPH034 is not known; therefore, the SRC will consider safety associated with potentially higher exposures and select an appropriate dose for the FE evaluation accordingly.
JPH034-treated participants (N = 6) from the selected SAD cohort will return for a pilot FE evaluation. Participants will undergo a washout prior to this FE evaluation (fasted dose on Day 1; fed dose on FE Day 1) for a minimum of 5 half-lives of JPH034. Participants will check into the clinic on FE Day -1 and will remain confined through the 48-hour PK collection on FE Day 3. On FE Day 1, participants will receive a single dose of JPH034 in a fed state (high-fat/high-calorie standard meal) following a minimum 10-hour overnight fast. Participants will have 30 minutes to ingest the entire meal, and the JPH034 dose will be administered 30 minutes after the start of the meal. Participants will then fast for at least 4 hours postdose.
For the SAD and FE cohorts safety assessments, as well as blood samples and urine collection for PK analyses will be performed. Participants will return to the clinic for PK collections 72 and 96 hours after administration of study intervention (Days 4 and 5, respectively). Seven to 9 days after administration of study intervention, participants will attend a follow-up visit.
- Conditions
- Health Adult Subjects
- Being tested
- JPH034, Placebo Control
- Keywords
- Single Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPH034Drug
Oral JPH034
Placebo ControlOther
Simple Syrup
| Study group | Role | What they receive |
|---|---|---|
| 1. SAD Cohort 1 - 20mg | Experimental | Single dose N = 6 JPH034: 2 Placebo Receives: Drug: JPH034; Other: Placebo Control |
| 2. SAD Cohort 2 - 40mg | Experimental | Single dose N = 6 JPH034: 2 Placebo Receives: Drug: JPH034; Other: Placebo Control |
| 3. SAD Cohort 3 - 80mg | Experimental | Single dose N = 6 JPH034: 2 Placebo Receives: Drug: JPH034; Other: Placebo Control |
| 4. SAD Cohort 4 -160mg | Experimental | Single dose N = 6 JPH034: 2 Placebo Receives: Drug: JPH034; Other: Placebo Control |
| 5. SAD Cohort 5 - TBD | Experimental | Single dose N = 6 JPH034: 2 Placebo Receives: Drug: JPH034; Other: Placebo Control |
| 6. SAD Food Effect - TBD | Experimental | Single dose N = 6 JPH034: 2 Placebo Receives: Drug: JPH034 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of JPH034 - Adverse Events
Frequency and severity of Adverse Events (AEs), including SAEs.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort .
Safety and Tolerability of JPH034 - Discontinuation of Study Intervention
Frequency of premature discontinuation of study intervention due to AEs.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort .
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.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
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.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of Heart Rate.
Clinically significant post dose measures for Heart Rate will be reported in beats/min.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of change from baseline for heart rate.
Clinically significant post dose measures for heart rate will be compared with the respective baseline value and the change will be reported in beats/min.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of blood pressure.
Clinically significant post dose measures for blood pressure will be reported in mmHg.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of change from baseline for blood pressure.
Clinically significant post dose measures for blood pressure will be compared with the respective baseline value and the change will be reported in mmHg.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of respiratory rate.
Clinically significant post dose measures for respiratory rate will be reported in breaths/min.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of change from baseline for respiratory rate.
Clinically significant post dose measures for respiratory rate will be compared with the respective baseline value and the change will be reported in breaths/min.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of body temperature.
Clinically significant post dose measures for body temperature will be reported in degrees centigrade.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of change from baseline for body temperature.
Clinically significant post dose measures for body temperature will be compared with the respective baseline value and the change will be reported in degrees centigrade.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of QTc interval on ECG.
Clinically significant QTc interval measurement on ECG will be reported in msec.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Safety and Tolerability of JPH034 - Measurement of change from baseline in QTc interval on ECG.
Clinically significant post dose measures for QTc interval measurement on ECG will be compared with the respective baseline value and the change will be reported in msec.
Measured: From first participant dosed to last participant completion (Day 9) in each cohort.
Secondary outcomes (2)
To characterize the single dose plasma PK of JPH034 and its metabolite (M1)
Plasma measurement of JPH034 and metabolite (M1).
Measured: PK sampling pre-dose to 96 hrs postdose for each participant.
To characterize the single dose urine PK of JPH034 and its metabolite (M1) in cohort 3
Urine measurement of JPH034 and metabolite (M1).
Measured: Urine sampling pre-dose to 24 hrs postdose for each participant in cohort 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start22 Mar 2026
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- J-Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534657
- Sponsor's protocol ID
- JPH034-P1-HV
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07534657
- Acronym / sponsor ID
- JPH034-P1-HV
- Conditions
- Health Adult Subjects
- Keywords
- Single Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- J-Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2026 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 managed using a sequential list. Participants will be permitted to participate in only 1 dose cohort of the study.
Single-Ascending Dose: The first SAD cohort will receive a dose of 20 mg JPH034 or placebo, and subsequent cohorts will receive anticipated escalating doses of JPH034 or placebo. Sentinel dosing will be utilized for all SAD cohorts. Eligible participants will check into the clinic on Day -1 and will remain confined through the 48-hour PK collection on Day 3. On Day 1, participants will receive a single dose of study intervention under fasted conditions.
Following completion of the observation period for the last participant in each cohort, the Safety Review Committee (SRC) will review available data from the observation period (including TEAEs, laboratory results, vital signs, ECGs, and PK data) and any cumulative data from prior cohorts. The observation period will be 7 days after administration of study intervention. The SRC may review unblinded data as necessary.
Pilot Food Effect: The FE evaluation will be performed at a safe dose level as determined by the SRC. The effect of food on the systemic exposure of JPH034 is not known; therefore, the SRC will consider safety associated with potentially higher exposures and select an appropriate dose for the FE evaluation accordingly.
JPH034-treated participants (N = 6) from the selected SAD cohort will return for a pilot FE evaluation. Participants will undergo a washout prior to this FE evaluation (fasted dose on Day 1; fed dose on FE Day 1) for a minimum of 5 half-lives of JPH034. Participants will check into the clinic on FE Day -1 and will remain confined through the 48-hour PK collection on FE Day 3. On FE Day 1, participants will receive a single dose of JPH034 in a fed state (high-fat/high-calorie standard meal) following a minimum 10-hour overnight fast. Participants will have 30 minutes to ingest the entire meal, and the JPH034 dose will be administered 30 minutes after the start of the meal. Participants will then fast for at least 4 hours postdose.
For the SAD and FE cohorts safety assessments, as well as blood samples and urine collection for PK analyses will be performed. Participants will return to the clinic for PK collections 72 and 96 hours after administration of study intervention (Days 4 and 5, respectively). Seven to 9 days after administration of study intervention, participants will attend a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1. SAD Cohort 1 - 20mg | Experimental | Drug: JPH034, Other: Placebo ControlSingle dose N = 6 JPH034: 2 Placebo |
| 2. SAD Cohort 2 - 40mg | Experimental | Drug: JPH034, Other: Placebo ControlSingle dose N = 6 JPH034: 2 Placebo |
| 3. SAD Cohort 3 - 80mg | Experimental | Drug: JPH034, Other: Placebo ControlSingle dose N = 6 JPH034: 2 Placebo |
| 4. SAD Cohort 4 -160mg | Experimental | Drug: JPH034, Other: Placebo ControlSingle dose N = 6 JPH034: 2 Placebo |
| 5. SAD Cohort 5 - TBD | Experimental | Drug: JPH034, Other: Placebo ControlSingle dose N = 6 JPH034: 2 Placebo |
| 6. SAD Food Effect - TBD | Experimental | Drug: JPH034Single dose N = 6 JPH034: 2 Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
- 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:
- Females with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Check-in (within 24 hours before the first dose of study intervention).
- Males who agree to the following conditions during the study intervention period and for at least 30 days after the last dose of study intervention:
Key exclusion criteria (30 listed)
- 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.
- Concurrent conditions that could interfere with safety and/or tolerability measurements, as determined by the Investigator or designee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JPH034Oral JPH034 | Drug | 1. SAD Cohort 1 - 20mg, 2. SAD Cohort 2 - 40mg, 3. SAD Cohort 3 - 80mg, 4. SAD Cohort 4 -160mg, 5. SAD Cohort 5 - TBD, 6. SAD Food Effect - TBD |
| Placebo ControlSimple Syrup | Other | 1. SAD Cohort 1 - 20mg, 2. SAD Cohort 2 - 40mg, 3. SAD Cohort 3 - 80mg, 4. SAD Cohort 4 -160mg, 5. SAD Cohort 5 - TBD |
Primary outcome
Safety and Tolerability of JPH034 - Adverse Events
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort .
Frequency and severity of Adverse Events (AEs), including SAEs.
Safety and Tolerability of JPH034 - Discontinuation of Study Intervention
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort .
Frequency of premature discontinuation of study intervention due to AEs.
Safety and Tolerability of JPH034 - Measurement of Clinical Safety (Chemistry, Hematology and Urinalysis) Laboratory Tests.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for Chemistry, Hematology and Urinalysis Laboratory tests will be reported using standardized units.
Safety and Tolerability of JPH034 - Measurement of the change from baseline of Clinical Safety (Chemistry, Hematology and Urinalysis) Laboratory Tests.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
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.
Safety and Tolerability of JPH034 - Measurement of Heart Rate.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for Heart Rate will be reported in beats/min.
Safety and Tolerability of JPH034 - Measurement of change from baseline for heart rate.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for heart rate will be compared with the respective baseline value and the change will be reported in beats/min.
Safety and Tolerability of JPH034 - Measurement of blood pressure.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for blood pressure will be reported in mmHg.
Safety and Tolerability of JPH034 - Measurement of change from baseline for blood pressure.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for blood pressure will be compared with the respective baseline value and the change will be reported in mmHg.
Safety and Tolerability of JPH034 - Measurement of respiratory rate.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for respiratory rate will be reported in breaths/min.
Safety and Tolerability of JPH034 - Measurement of change from baseline for respiratory rate.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for respiratory rate will be compared with the respective baseline value and the change will be reported in breaths/min.
Safety and Tolerability of JPH034 - Measurement of body temperature.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for body temperature will be reported in degrees centigrade.
Safety and Tolerability of JPH034 - Measurement of change from baseline for body temperature.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for body temperature will be compared with the respective baseline value and the change will be reported in degrees centigrade.
Safety and Tolerability of JPH034 - Measurement of QTc interval on ECG.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant QTc interval measurement on ECG will be reported in msec.
Safety and Tolerability of JPH034 - Measurement of change from baseline in QTc interval on ECG.
Time frame: From first participant dosed to last participant completion (Day 9) in each cohort.
Clinically significant post dose measures for QTc interval measurement on ECG will be compared with the respective baseline value and the change will be reported in msec.
2 secondary outcomes
To characterize the single dose plasma PK of JPH034 and its metabolite (M1)
Time frame: PK sampling pre-dose to 96 hrs postdose for each participant.
To characterize the single dose urine PK of JPH034 and its metabolite (M1) in cohort 3
Time frame: Urine sampling pre-dose to 24 hrs postdose for each participant in cohort 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JPH034 in people with Health Adult Subjects, run by J-Pharma Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Masuhiro Yoshitake (+81-3-6432-4270, yoshitake@j-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of JPH034 - Adverse Events (time frame: From first participant dosed to last participant completion (Day 9) in each cohort .). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.