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

NCT06482346 | Completed Phase 1

• 2 other identifiers: MT-3534-Z-101jRCT2031240187
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

MT-3534

EXPERIMENTAL

Intravenous (IV)

Biological: MT-3534

Placebo

PLACEBO COMPARATOR

Intravenous (IV)

Biological: Placebo

Interventions

MT-3534 BIOLOGICAL

Solution for infusion; Intravenous (IV)

MT-3534

Placebo BIOLOGICAL

Solution for infusion; Intravenous (IV)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 160-0004, Japan

Location

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: August 9, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)