Clinical trial NCT06482346: Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers
Official title: Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers (SAD Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Adult Male Volunteers
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: up to Day 85
measure: Number of subjects with adverse reactions
timeFrame: up to Day 85
measure: Serum concentrations of MT-3534
timeFrame: up to Day 85
Secondary outcomes:
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
state: Tokyo
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: