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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male Volunteers
• Intervention / Treatment: Biological: Placebo; Biological: MT-3534

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-0004
      • Clinical Research Hospital Tokyo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intravenous (IV)	Biological: Placebo; Solution for infusion; Intravenous (IV)
Experimental: MT-3534; Intravenous (IV)	Biological: MT-3534; Solution for infusion; Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Investigators: Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MT-3534-Z-101; jRCT2031240187 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No