NIPH Clinical Trials Search

Phase 1 Clinical Study of JTE-461 -Single and Multiple Dose Study-

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic Spontaneous Urticaria
Date of first enrollment	21/01/2026
Target sample size	88
Countries of recruitment
Study type	Interventional
Intervention(s)	<Part 1> Single dose administration of JTE-461 or placebo in the fed or fasted state. <Part 2> Multiple dose administration of JTE-461 or placebo for 15 consecutive days and single doses of midazolam on 2 days in the fed state.

Outcome(s)

Primary Outcome	Safety, Pharmacokinetics
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 45age old
Gender	Male
Include criteria	(1) Healthy Japanese males aged 18 to 45 years (inclusive) at the time of obtaining informed consent (2) Participants with a BMI of >= 18.5 to < 25.0 at the Screening Visit (3) Participants who have given written informed consent to participate in this study
Exclude criteria	(1) Participants who have a serious medical history of, or are currently under treatment for the brain, liver, kidney, lung, gastrointestinal, hematologic, endocrine, metabolic, psychiatric, or other systems (2) Participants who have a history of gastrointestinal surgery that could interfere with drug absorption (3) Participants meeting any of the following criteria according to the result of screening test performed at the Screening Visit - Participants with deviations from reference values of systolic blood pressure (90 to 139 mmHg) - Participants with deviations from reference values of diastolic blood pressure (40 to 89 mmHg) - Participants who do not receive negative test results in the immunological test (HBs antigen, HCV antibody, serological test for syphilis [TP antibody method, RPR method], HIV antigen/antibody) or urine screening test for drugs of abuse - Participants who are ineligible for study participation in the opinion of the investigator or subinvestigator (4) Participants with a history of or current arrhythmia or clinically significant cardiac disease, or a history of risk factors for Torsades de Pointes (family history of sudden death, unexplained syncope, heart failure, hypokalemia, family history of long QT syndrome) (5) Participants who are determined by the investigator or subinvestigator that any clinically important abnormalities in the 12-lead ECG at the Screening Visit or on the day of admission may interfere with the interpretation of changes in the QTc interval (6) Participants meeting any of the following criteria according to the result of pulse rate or 12-ECG performed at the Screening Visit or on the day of admission - Participants with deviations from reference values of pulse rate (40 to 99 beats/min) - Participants with deviations from reference values of QTcF (<450 ms) - Participants with deviations from reference values of QRS duration (<110 ms) - Participants with deviations from reference values of PR interval (<210 ms) (7) Participants with a history of or current drug allergy (8) Participants with a history of or current drug or alcohol dependence (9) Participants who have used drugs (excluding ophthalmic drugs other than antibacterial ophthalmic solutions and other drugs considered by the investigator or subinvestigator not to affect the study) within 1 week before the day of admission (10) Participants who have used any drugs that prolong the QT/QTc interval within 2 weeks before the day of admission (11) Participants who have used any drugs that induce or inhibit the CYP3A4 within 2 weeks before the day of admission (12) Participants who have consumed citrus (including grapefruit juice and orange juice) within 1 week before the day of admission (13) Participants who have consumed food or beverages containing St. John's wort or its components within 2 weeks before the day of admission (14) Participants who have smoked or used nicotine-containing products (e.g., cigar, nicotine patch) within 4 weeks before the day of admission (15) Participants who have undergone blood collection of more than 400 mL within 12 weeks or more than 200 mL within 4 weeks before the day of admission (except for the blood collection for this study in either case), or who donated blood components within 2 weeks before the day of admission (16) Participants who have been treated with any investigational products, study drugs, or procedures within 16 weeks or 5 times the half-life (whichever is longer) before the day of admission in another clinical study including that of a medical device or a clinical trial that may affect this study (17) Participants who have not consented to abstain from sexual intercourse or use appropriate contraceptive methods when engaging in sexual intercourse from the time of admission to the completion of assessments on the end-of-study date (18) Participants who previously participated in this study and received the investigational product (19) Participants who are contraindicated for the administration of midazolam according to the latest package insert for midazolam (Only in Part 2) (20) Other than above, participants who are ineligible for study participation in the opinion of the investigator or subinvestigator