Healthy VolunteersPhase 1NCT03055403
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
A Phase 1 study testing M201-A Injection in people with Healthy Volunteers, run by Yuji KUMAGAI at 1 site in Japan.
Trial summary
This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- M201-A Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 17 Feb 2017to 28 Nov 2017
- 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 20 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Japanese Healthy Male subjects
- Age 20 to less than 40 years of age
- Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
- Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
- Past medical history of cancer, cerebral infarction or cardiac infarction
- Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
- QTcF > 450ms at the screening examination
- NT-proBNP > 125 pg/mL at the screening examination
- Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
Trial locations and contacts
1 site in 1 country.
Japan1 site
Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE
Sagamihara, Kanagawa, 252-0375
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
Read the detailed description
Not Provided
- Conditions
- Healthy Volunteers
- Being tested
- M201-A Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M201-A InjectionDrug
Active Substance: M201-A Route of administration: continuous intravenous injection
PlaceboDrug
Saline Placebo for M201-A Route of administration: continuous intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| M201-A Injection | Experimental | Active Substance: M201-A Route of administration: continuous intravenous injection Receives: Drug: M201-A Injection |
| Placebo | Placebo comparator | Saline Placebo for M201-A Route of administration: continuous intravenous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
Measured: Throughout the study duration (up to day8)
Secondary outcomes (10)
Pharmacokinetics-Cmax
Observed maximum plasma concentration (Cmax) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-Tmax
Time to Cmax (Tmax) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-24
Area under the plasma concentration-time curve from time zero to 24hour of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-t
-Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-∞
Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-t1/2
Elimination half-life (t1/2) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-CL
Apparent clearance of drug from plasma (CL) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-Vd
Apparent volume of distribution during the terminal phase (Vd) of M201-A
Measured: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-E0-24
Amount of drug excreted in urine from time zero to 24hour of M201-A
Measured: up to 24 hours
Pharmacokinetics-Ae
Urinary excretion rate of M201-A
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start17 Feb 2017
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuji KUMAGAI
- Sponsor type
- University, hospital or other
- Collaborators
- Aetas Pharma Co. Ltd.
- Responsible party
- Sponsor-investigator, Yuji KUMAGAI, Kitasato University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055403
- Sponsor's protocol ID
- M201-A-CT-001
- Status last verified
- Nov 2021
- First submitted
- 10 Feb 2017
- Last updated
- 30 Nov 2021
- 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 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03055403
- Acronym / sponsor ID
- M201-A-CT-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuji KUMAGAIUniversity, hospital or other
- Collaborators
- Aetas Pharma Co. Ltd.
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 16 Feb 2017 (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 Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
Detailed description
Not Provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M201-A Injection | Experimental | Drug: M201-A InjectionActive Substance: M201-A Route of administration: continuous intravenous injection |
| Placebo | Placebo comparator | Drug: PlaceboSaline Placebo for M201-A Route of administration: continuous intravenous injection |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese Healthy Male subjects
- Age 20 to less than 40 years of age
- Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
- Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Key exclusion criteria (7 listed)
- Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
- Past medical history of cancer, cerebral infarction or cardiac infarction
- Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
- QTcF > 450ms at the screening examination
- NT-proBNP > 125 pg/mL at the screening examination
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 |
|---|---|---|
| M201-A InjectionActive Substance: M201-A Route of administration: continuous intravenous injection | Drug | M201-A Injection |
| PlaceboSaline Placebo for M201-A Route of administration: continuous intravenous injection | Drug | Placebo |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Throughout the study duration (up to day8)
adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.
10 secondary outcomes
Pharmacokinetics-Cmax
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-Tmax
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-24
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-t
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-AUC0-∞
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-t1/2
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-CL
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-Vd
Time frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Pharmacokinetics-E0-24
Time frame: up to 24 hours
Pharmacokinetics-Ae
Time frame: up to 24 hours
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 30 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 M201-A Injection in people with Healthy Volunteers, run by Yuji KUMAGAI 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 5 inclusion and 7 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 30 Nov 2021. 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 participants with adverse events as a measure of safety and tolerability (time frame: Throughout the study duration (up to day8)). 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 30 Nov 2021.