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New treatment option for Health Adult Subjects
Official title A Study of JPH034 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07534657
What this study is testing
What is JPH034?
JPH034 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for health adult subjects.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, hematological, neurological, or psychiatric disorders...
- 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...
- Concurrent conditions that could interfere with safety and/or side effects 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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.
What rules you out
- History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or...
- 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...
- Concurrent conditions that could interfere with safety and/or side effects 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dilworth, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dilworth, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.