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.
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.
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
- Conditions
- Healthy Adult Males
- 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 group | Role | What they receive |
|---|---|---|
| MT-3921 | Experimental | Intravenous (IV) Receives: Biological: MT-3921 |
| Placebo | Placebo comparator | Intravenous (IV) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with adverse events
Measured: 16 weeks
Percentage of subjects with adverse reactions
Measured: 16 weeks
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.
- First posted31 May 2022
- Study start3 Aug 2022
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT05396235
- Acronym / sponsor ID
- MT-3921-Z-101
- Conditions
- Healthy Adult Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-3921 | Experimental | Biological: MT-3921Intravenous (IV) |
| Placebo | Placebo comparator | Biological: PlaceboIntravenous (IV) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-3921Also: UnasnemabSolution for infusion; Intravenous (IV) | Biological | MT-3921 |
| PlaceboSolution for infusion; Intravenous (IV) | Biological | Placebo |
Primary outcome
Percentage of subjects with adverse events
Time frame: 16 weeks
Percentage of subjects with adverse reactions
Time frame: 16 weeks
Time course of serum concentrations of MT-3921
Time frame: Day 1, 2, 3, 4, 8, 15, 29, 57, 85, and 113.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
1 site in 1 country: see every site and its status.
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.