Healthy Adult Male VolunteersPhase 1NCT06482346
Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers
A Phase 1 study testing MT-3534 in people with Healthy Adult Male Volunteers, run by Tanabe Pharma Corporation at 1 site in Japan.
Trial summary
This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers. 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 Male Volunteers
- What is being tested?
- MT-3534
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- 9 Aug 2024to 9 Jul 2025
- 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
Who may be able to join
- Healthy adult male volunteer
- Japanese (Part A) or White (Part B)
- Subjects with age of 18 to 55 years old at informed consent
- Subjects with a full understanding of the nature of this study and consented in writing to participate in the study
Who cannot join
- Additional screening criteria check may apply for qualification:
- Subjects with a current or prior disease history of cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, endocrine systems, etc. whom the investigator has judged to be unfit for study participation
- Subjects with a history of drug or food allergies
- Subjects with a history of hypersensitivity to any of the ingredients of MT-3534
- Subjects whose BMI is less than 18.5 kg/m^2 or exceeds 25.0 kg/m^2, or subjects weighing less than 50.0 kg or exceeds 80.0 kg at the time of screening or Day -1 tests (Part A). Subjects whose BMI is less than 18.5 kg/m^2 or exceeds 30.0 kg/m^2, or subjects weighing less than 50.0 kg or exceeds 100.0 kg at the time of screening or Day -1 tests (Part B). (For BMI, values rounded to the first decimal place will be used.)
- Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more in the 12 weeks, 200 mL or more in the 4 weeks, or 800 mL or more in the 52 weeks prior to informed consent
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- Subjects who have donated blood platelets or from whom blood samples have been collected in the 2 weeks prior to informed consent
- Subjects with a current or prior history of dependence on drugs, alcohol, etc
- Subjects with a history of cancer
- Subjects who receive a live attenuated vaccine within 4 weeks before the start of investigational product administration
- Subjects with a positive result for serological test for syphilis, Hepatitis C virus (HCV) antibody, or HIV antigen/antibody at screening
- Subjects with a positive result for Hepatitis B virus surface (HBs) antigen, Hepatitis B virus core (HBc) antibody and HBs antibody at screening (Subjects with a negative for HBs antigen plus a positive for HBs antibody plus a negative for HBc antibody and who have obvious history of vaccination are eligible to enroll)
- Subjects with a history of recurrent infections such as Herpes simplex or Herpes zoster
- Subjects with a positive result for polymerase chain reaction (PCR) test for COVID-19 at Day -1 test
- Subjects who do not agree to contraception from the date of informed consent until 12 weeks after the end of the administration of the 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 the 7 days before the start of investigational product administration or 5 times the half-life of the drug, whichever is longer
- Subjects judged by the investigator (or subinvestigator) to be ineligible for the study for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers (SAD Study)
This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers.
- Conditions
- Healthy Adult Male Volunteers
- Being tested
- MT-3534, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-3534Biological
Solution for infusion; Intravenous (IV)
PlaceboBiological
Solution for infusion; Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| MT-3534 | Experimental | Intravenous (IV) Receives: Biological: MT-3534 |
| 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.
Number of subjects with adverse events
Measured: up to Day 85
Number of subjects with adverse reactions
Measured: up to Day 85
Serum concentrations of MT-3534
Measured: up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start9 Aug 2024
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male VolunteersStudies 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
- 56 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
- NCT06482346
- Sponsor's protocol ID
- MT-3534-Z-101
- Other IDs
- jRCT2031240187
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers (SAD Study)
- ClinicalTrials.gov ID
- NCT06482346
- Acronym / sponsor ID
- MT-3534-Z-101
- Conditions
- Healthy Adult Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 1 Jul 2024 (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.
This study is planned to investigate the safety, tolerability, and pharmacokinetics when a single intravenous dose of MT-3534 or a placebo is given to healthy adult male volunteers.
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-3534 | Experimental | Biological: MT-3534Intravenous (IV) |
| Placebo | Placebo comparator | Biological: PlaceboIntravenous (IV) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult male volunteer
- Japanese (Part A) or White (Part B)
- Subjects with age of 18 to 55 years old at informed consent
- Subjects with a full understanding of the nature of this study and consented in writing to participate in the study
Key exclusion criteria (18 listed)
- Subjects with a current or prior disease history of cardiac, hepatic, renal, gastrointestinal, respiratory, neuropsychiatric, hematopoietic, endocrine systems, etc. whom the investigator has judged to be unfit for study participation
- Subjects with a history of drug or food allergies
- Subjects with a history of hypersensitivity to any of the ingredients of MT-3534
- Subjects whose BMI is less than 18.5 kg/m^2 or exceeds 25.0 kg/m^2, or subjects weighing less than 50.0 kg or exceeds 80.0 kg at the time of screening or Day -1 tests (Part A). Subjects whose BMI is less than 18.5 kg/m^2 or exceeds 30.0 kg/m^2, or subjects weighing less than 50.0 kg or exceeds 100.0 kg at the time of screening or Day -1 tests (Part B). (For BMI, values rounded to the first decimal place will be used.)
- Subjects who have donated blood or from whom blood samples have been collected in a total amount of 400 mL or more in the 12 weeks, 200 mL or more in the 4 weeks, or 800 mL or more in the 52 weeks prior to informed consent
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-3534Solution for infusion; Intravenous (IV) | Biological | MT-3534 |
| PlaceboSolution for infusion; Intravenous (IV) | Biological | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to Day 85
Number of subjects with adverse reactions
Time frame: up to Day 85
Serum concentrations of MT-3534
Time frame: up to Day 85
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 5 Aug 2025.
- 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-3534 in people with Healthy Adult Male Volunteers, 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?
The sponsor lists 4 inclusion and 18 exclusion criteria. 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 5 Aug 2025. 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?
Number of subjects with adverse events (time frame: up to Day 85). 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 5 Aug 2025.