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Healthy Adult MalesPhase 1NCT05396235

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

A Phase 1 study testing MT-3921 in people with Healthy Adult Males, run by Tanabe Pharma Corporation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Adult Males
What is being tested?
MT-3921
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteJapan
Study dates
3 Aug 2022to 24 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

1 site in 1 country.

Japan1 site
  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 162-0053

Other trials in Japan

About this study

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

Being tested
MT-3921, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MT-3921Biological

    Also called Unasnemab

    Solution for infusion; Intravenous (IV)

  • PlaceboBiological

    Solution for infusion; Intravenous (IV)

Study groups in NCT05396235
Study groupRoleWhat they receive
MT-3921ExperimentalIntravenous (IV)
Receives: Biological: MT-3921
PlaceboPlacebo comparatorIntravenous (IV)
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with adverse events

    Measured: 16 weeks

  2. Percentage of subjects with adverse reactions

    Measured: 16 weeks

  3. Time course of serum concentrations of MT-3921

    Measured: Day 1, 2, 3, 4, 8, 15, 29, 57, 85, and 113.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start3 Aug 2022
  3. Primary completion24 Dec 2022
  4. Study completion24 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05396235
Sponsor's protocol ID
MT-3921-Z-101
Other IDs
jRCT2031220182
Status last verified
Jan 2023
First submitted
22 May 2022
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MT-3921 in people with Healthy Adult Males, run by Tanabe Pharma Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with adverse events (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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