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

Healthy Adult Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396235
• Other study ID #: MT-3921-Z-101
• Secondary ID: jRCT2031220182
• Status: Completed
• Phase: Phase 1
• Start date: August 3, 2022
• Est. completion date: December 24, 2022

Study information

• Verified date: January 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 24, 2022
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Males

Intervention

Biological:
• MT-3921
Solution for infusion; Intravenous (IV)
• Placebo
Solution for infusion; Intravenous (IV)

Locations

Country	Name	City	State
Japan	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with adverse events		16 weeks
Primary	Percentage of subjects with adverse reactions		16 weeks
Primary	Time course of serum concentrations of MT-3921		Day 1, 2, 3, 4, 8, 15, 29, 57, 85, and 113.