Clinical trial
MT-3534 Clinical Pharmacology Study in Healthy Adult Male Volunteers (SAD Study)
Name
MT-3534-Z-101
Description
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.
Trial arms
Trial start
2024-08-01
Estimated PCD
2025-07-01
Trial end
2025-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
MT-3534
Solution for infusion; Intravenous (IV)
Arms:
MT-3534
Placebo
Solution for infusion; Intravenous (IV)
Arms:
Placebo
Size
56
Primary endpoint
Number of subjects with adverse events
up to Day 85
Number of subjects with adverse reactions
up to Day 85
Serum concentrations of MT-3534
up to Day 85
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}
Updated at
2024-07-01
1 organization
1 product
1 drug
1 indication
Organization
Mitsubishi Tanabe PharmaProduct
MT-3534Indication
Healthy Adult Male VolunteersDrug
Varlilumab