Clincosm LogoSign in Get a demo

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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05396235
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
3.9
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: MT-3921
  • Biological: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males
Actual Study Start Date :
Aug 3, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects with adverse events [16 weeks]

    2. Percentage of subjects with adverse reactions [16 weeks]

    3. Time course of serum concentrations of MT-3921 [Day 1, 2, 3, 4, 8, 15, 29, 57, 85, and 113.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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/m2 or greater than 25 kg/m2 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Hospital Tokyo Shinjuku-ku Tokyo Japan 162-0053

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT05396235
    Other Study ID Numbers:
    • MT-3921-Z-101
    First Posted:
    May 31, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 24, 2022