Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers
Phase 1
Active, not recruiting
- Conditions
- Healthy Adult Male Volunteers
- Interventions
- Biological: Placebo
- Registration Number
- NCT06482346
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_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 Serum concentrations of MT-3534 up to Day 85 Number of subjects with adverse reactions up to Day 85 Number of subjects with adverse events up to Day 85
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Hospital Tokyo
🇯🇵Shinjuku-ku, Tokyo, Japan
Clinical Research Hospital Tokyo🇯🇵Shinjuku-ku, Tokyo, Japan