Healthy VolunteersPhase 1NCT04464681
Multiple 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 Kitasato University at 1 site in Japan.
Trial summary
This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 49 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
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 30 Mar 2020to 30 Nov 2020
- 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 49 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
- (1)Japanese Healthy Male subjects
- (2)Age 20 to less than 50 years of age
- (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination
- (4)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:
- (1)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
- (2)Past medical history of cancer, cerebral infarction or cardiac infarction
- (3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation.
- (4)Presence or past history of epilepsy.
- (5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
Show all 24Show fewer
- (6)heart rate(HR) >= 100 bpm at the screening examination
- (7)The corrected QT interval(QTcF) >= 440 ms at the screening examination
- (8)brain natriuretic peptide(BNP) > 40 pg/mL at the screening examination
- (9)K<3.6 mEq/L at the screening examination
- (10)Past history or suspect of aldosteronism.
- (11)Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
- (12)Cre>1.10 mg/dL, <0.85 mg/dL at the screening examination
- (13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL of 200 mL / blood component donation within 4weeks prior to the first administration.
- (14)Use of prescription drug, over-the-counter medications (except eye drops for dryness, sanitizer for preventing infection), or herbal medication within 4 weeks prior to study medication.
- (15)Subject who consumed furanocoumarin containing food within 7 days prior to study medication.
- (16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to study medication.
- (17)Subject who was administered of another investigational drug within16 weeks prior to agree to participate in this study.
- (18)Subject who was administered M201-A in the past.
- (19)Subject who smoke within 90 day prior to study medication or who cannot quit smoking during the study period.
- (20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV) antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test. Subject with positive result in Coronavirus(COVID-19) test at the screening or at the hospitalization.
- (21) Presence or past history of drug/alcohol abuse.
- (22)Subject who do not use medically acceptable contraceptive method until 90 days after the final study drug administration.
- (23)Subject who investigator judges ineligible for other reasons
Trial locations and contacts
1 site in 1 country.
Japan1 site
Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL
Tokyo, 108-8642
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple 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 is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
- 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
Placebo: M201-A Placebo 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 | Placebo: M201-A Placebo 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
Number of participants with 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 day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start30 Mar 2020
- Primary completion28 Nov 2020
- Study completion30 Nov 2020
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kitasato University
- Sponsor type
- University, hospital or other
- Collaborators
- Aetas Pharma Co. Ltd.
- Responsible party
- Principal investigator, Tomoko Hasunuma, Kitasato University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464681
- Sponsor's protocol ID
- M201-A-CT-003
- Status last verified
- Aug 2021
- First submitted
- 5 Jul 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple 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
- NCT04464681
- Acronym / sponsor ID
- M201-A-CT-003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kitasato UniversityUniversity, hospital or other
- Collaborators
- Aetas Pharma Co. Ltd.
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 9 Jul 2020 (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 is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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: PlaceboPlacebo: M201-A Placebo Route of administration: continuous intravenous injection |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must satisfy the following criteria to be enrolled in the study
- (1)Japanese Healthy Male subjects
- (2)Age 20 to less than 50 years of age
- (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination
- (4)Written informed consent must be obtained on a voluntary basis before any assessment is performed.
Key exclusion criteria (24 listed)
- (1)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
- (2)Past medical history of cancer, cerebral infarction or cardiac infarction
- (3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation.
- (4)Presence or past history of epilepsy.
- (5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
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 |
| PlaceboPlacebo: M201-A Placebo 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 day 11
Number of participants with 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.
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 31 Aug 2021.
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Pain
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 Kitasato University 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 24 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 31 Aug 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 day 11). 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 31 Aug 2021.