A Study of JPH034 in Healthy Adult Participants

Exclusion Criteria30

• 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.
• 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.