Single-dose testing of JPH034 in healthy adults.

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 trial tests single ascending doses of the experimental drug JPH034 versus placebo in healthy adults aged 18–50 to see if the drug is safe, how the body handles it, and whether food affects absorption.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: J-Pharma Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Dilworth, Minnesota)
• Trial ID: NCT07534657 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, double-blind, placebo-controlled single-ascending dose study will enroll healthy adults aged 18–50 to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JPH034. Participants will be randomized to JPH034 or placebo in escalating dose cohorts with sentinel dosing and will remain confined for in-clinic safety and PK sampling through 48 hours plus a seven-day observation period. An unblinded pilot food-effect cohort will compare PK after a high-fat meal versus fasted dosing. A Safety Review Committee will review safety, lab, ECG, and PK data before dose escalation.

Who should consider this trial

Good fit: Healthy adults aged 18–50 with BMI 18.5–34 kg/m2 who are not pregnant or breastfeeding and who meet the study's contraception and health criteria are eligible.

Not a fit: People with active medical conditions, those outside the age or BMI ranges, or individuals seeking immediate therapeutic benefit for a disease are unlikely to receive direct health benefit from participation.

Why it matters

Potential benefit: If safe, the trial could identify a tolerated dose and PK profile to support further clinical testing of JPH034.

How similar studies have performed: Single-ascending-dose, placebo-controlled Phase 1 trials are a standard, well-established approach for first-in-human PK and safety, though no prior positive results for JPH034 are reported here.

Eligibility criteria

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, bilateral salpingectomy, or bilateral oophorectomy), or
   3. 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.
4. 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).
5. 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:

   1. Refrain from donating sperm and
   2. 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.
6. Willing and able to provide voluntary, written informed consent to participate in the study.
7. Able to communicate well with the Investigator and/or study site personnel and to comply with the requirements of the entire study.
8. Negative drug/alcohol testing at Screening and Check-in.
9. 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.

   1. Systolic BP, 90 to 140 mmHg, inclusive
   2. Diastolic BP, 50 to 90 mmHg, inclusive
   3. Heart rate (HR), \> 45 to ≤ 100 bpm
10. 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.

Exclusion Criteria:

1. 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.
2. History of any active infection within 14 days of dosing with study intervention, if deemed clinically significant by the Investigator and Sponsor.
3. Any acute illness within 30 days prior to dosing with study intervention.
4. 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.
5. Concurrent conditions that could interfere with safety and/or tolerability measurements, as determined by the Investigator or designee.
6. 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.
7. 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).
8. History of a major psychiatric disorder, ongoing suicidal ideations, or endorsement of suicidal ideation or behavior based on the C-SSRS at Screening.
9. Reduced sense of taste, as assessed by taste strips at Screening.
10. QTcF \> 450 msec for males or \> 470 msec for females observed at Screening or Check-in.
11. History or presence of any type of arrhythmia or irregular heartbeat.
12. Long QT syndrome or a history of cardiac disease.
13. 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).
14. Use of any drug known to prolong the QT interval within 4 weeks prior to study.
15. ALT or AST \> 1.5 × ULN at Screening or Check-in.
16. 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.
17. 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.
18. Use of prescription or non-prescription medications within 14 days or 5 half-lives, whichever is longer, before the first dose of study intervention.
19. Exposure to any investigational agent within 5 half-lives or 30 days, whichever is longer, prior to Screening.
20. Diagnosis of or positive Screening result for HCVAb, or HIV-1 or HIV-2.
21. 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.
22. Positive COVID-19 test.
23. Positive or indeterminate IGRA (QuantiFERON®-TB Gold Plus \[QFT-Plus\]) TB test.
24. Known history of allergy to JPH034 or other related drugs or their components.
25. 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.
26. Unable to ingest an entire high-fat/high-calorie meal.
27. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.
28. Plasma donation within 7 days of Screening.
29. Unable or unwilling to cooperate with site staff for any reason.
30. 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.

Where this trial is running

Dilworth, Minnesota

• Axis Clinicals Phase 1 Unit — Dilworth, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Masuhiro Yoshitake

Conditions Health Adult Subjects; Single Ascending Dose