A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics when MT-3921 or a placebo is intravenously given to Japanese healthy adult male subjects

Study Overview

• Status: Completed
• Conditions: Healthy Adult Males
• Intervention / Treatment: Biological: MT-3921; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 162-0053
      • Clinical Research Hospital Tokyo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria: Additional screening criteria check may apply for qualification:

• Japanese healthy adult males
• Subjects aged between 18 and 55 years inclusive at the time of informed consent
• Subjects with a full understanding of the nature of this study who have consented in writing to participate in the study

Exclusion Criteria: Additional screening criteria check may apply for qualification:

• Subjects with or having a history or treatment history of disorders, including cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, or endocrine system disorder, who are judged by the investigator (or subinvestigator) to be unfit for study participation
• Subjects with a history of drug or food allergies, including anaphylaxis or significant allergic reactions
• Subjects with a body mass index (BMI) of less than 18.5 kg/m^2 or greater than 25 kg/m^2 at the time of screening or Day -1 or those with a body weight of less than 50 kg or greater than 80 kg
• Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more within 12 weeks prior to informed consent, 200 mL or more within 4 weeks prior to informed consent, or 800 mL or more within 1 year prior to informed consent
• Subjects who have donated blood component or platelet apheresis within 2 weeks prior to informed consent
• Subjects with or having a history of drug dependence or alcohol dependence
• Subjects with clinically significant abnormalities on a 12-lead ECG, with a Fridericia-corrected QT (QTcF) interval of ≥450 msec, or with clinically significant abnormalities on an auscultation
• Subjects with a positive result for hepatitis B virus surface (HBs) antigen, serological test for syphilis, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody at screening
• Subjects with a positive polymerase chain reaction (PCR) test for Coronavirus disease 2019 (COVID-19)
• Subjects with a family history of sudden death
• Subjects who answered "yes" to any of the items of suicide ideation or suicide attempts in the Columbia Suicide Rating Scale (C-SSRS) assessment in the screening period
• Subjects who do not agree to practice contraception during the study period
• Subjects who have previously received anti-RGMa antibodies, including this 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 7 days before the start of investigational product administration or 5 times the half-life of the drug, whichever is longer

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
Experimental: MT-3921; Intravenous (IV)	Biological: MT-3921; Solution for infusion; Intravenous (IV); Other Names: Unasnemab
Placebo Comparator: Placebo; Intravenous (IV)	Biological: Placebo; Solution for infusion; Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with adverse events	16 weeks
Percentage of subjects with adverse reactions	16 weeks
Time course of serum concentrations of MT-3921	Day 1, 2, 3, 4, 8, 15, 29, 57, 85, and 113.

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): December 24, 2022
• Study Completion (Actual): December 24, 2022

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MT-3921-Z-101; jRCT2031220182 (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: Yes
• Studies a U.S. FDA-regulated device product: No