Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers

Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers (SAD Study)

NCT06482346•Tanabe Pharma Corporation

Summary

This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adult male volunteer
•Japanese (Part A) or White (Part B)
•Subjects with age of 18 to 55 years old at informed consent
•Subjects with a full understanding of the nature of this study and consented in writing to participate in the study

Exclusion Criteria

•Additional screening criteria check may apply for qualification:
•Subjects with a current or prior disease history of cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, endocrine systems, etc. whom the investigator has judged to be unfit for study participation
•Subjects with a history of drug or food allergies
•Subjects with a history of hypersensitivity to any of the ingredients of MT-3534
•Subjects whose BMI is less than 18.5 kg/m\^2 or exceeds 25.0 kg/m\^2, or subjects weighing less than 50.0 kg or exceeds 80.0 kg at the time of screening or Day -1 tests (Part A). Subjects whose BMI is less than 18.5 kg/m\^2 or exceeds 30.0 kg/m\^2, or subjects weighing less than 50.0 kg or exceeds 100.0 kg at the time of screening or Day -1 tests (Part B). (For BMI, values rounded to the first decimal place will be used.)
•Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more in the 12 weeks, 200 mL or more in the 4 weeks, or 800 mL or more in the 52 weeks prior to informed consent
•Subjects who have donated blood platelets or from whom blood samples have been collected in the 2 weeks prior to informed consent
•Subjects with a current or prior history of dependence on drugs, alcohol, etc
•Subjects with a history of cancer
•Subjects who receive a live attenuated vaccine within 4 weeks before the start of investigational product administration
+8 more criteria

Locations (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Key Dates

Start Date

August 9, 2024

Primary Completion Date

July 9, 2025

Completion Date

July 9, 2025

Last Updated

August 5, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male Volunteers

Interventions

MT-3534

BIOLOGICAL

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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