Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects

August 29, 2021 updated by: Tomoko Hasunuma, Kitasato University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 108-8642
        • Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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
  • (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
Drug: M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
Placebo Comparator: Placebo
Placebo: M201-A Placebo Route of administration: continuous intravenous injection
Drug: Placebo
Placebo: M201-A Placebo Route of administration: continuous intravenous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Throughout the study duration up to day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kitasato University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aetas Pharma Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M201-A-CT-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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