MT-3534 Clinical Pharmacology Study in Healthy Adult Male Volunteers

Recruitment & Eligibility

Status: NOT_YET_RECRUITING

Sex: Male

Target Recruitment: 56

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
Subjects with a positive result for serological test for syphilis, Hepatitis C virus (HCV) antibody, or HIV antigen/antibody at screening
Subjects with a positive result for Hepatitis B virus surface (HBs) antigen, Hepatitis B virus core (HBc) antibody and HBs antibody at screening (Subjects with a negative for HBs antigen plus a positive for HBs antibody plus a negative for HBc antibody and who have obvious history of vaccination are eligible to enroll)
Subjects with a history of recurrent infections such as Herpes simplex or Herpes zoster
Subjects with a positive result for polymerase chain reaction (PCR) test for COVID-19 at Day -1 test
Subjects who do not agree to contraception from the date of informed consent until 12 weeks after the end of the administration of the investigational product
Subjects who have participated in other clinical studies and received other investigational products within 12 weeks before informed consent
Subjects who have used any drug other than the investigational product in the period within the 7 days before the start of investigational product administration or 5 times the half-life of the drug, whichever is longer
Subjects judged by the investigator (or subinvestigator) to be ineligible for the study for any other reason

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intravenous (IV)
MT-3534	MT-3534	Intravenous (IV)

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse reactions	up to Day 85
Number of subjects with adverse events	up to Day 85
Serum concentrations of MT-3534	up to Day 85

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Clinical Research Hospital Tokyo
🇯🇵
Shinjuku-ku, Tokyo, Japan

MT-3534 Clinical Pharmacology Study in Healthy Adult Male Volunteers

Recruitment & Eligibility

Study & Design

Trial Locations

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