First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects

November 28, 2021 updated by: Yuji KUMAGAI

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.

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.

Detailed Description

Not Provided

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.
40

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
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE

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 39 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:

  • 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.

Exclusion Criteria:

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

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: PARALLEL
  • 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
Saline Placebo for M201-A Route of administration: continuous intravenous injection
Drug: Placebo
Saline Placebo for M201-A 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 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.
Throughout the study duration (up to day8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics-Cmax
Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
Observed maximum plasma concentration (Cmax) of M201-A
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
Time to Cmax (Tmax) of M201-A
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
Area under the plasma concentration-time curve from time zero to 24hour of M201-A
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
-Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A
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
Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A
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
Elimination half-life (t1/2) of M201-A
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
Apparent clearance of drug from plasma (CL) of M201-A
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
Apparent volume of distribution during the terminal phase (Vd) of M201-A
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
Amount of drug excreted in urine from time zero to 24hour of M201-A
up to 24 hours
Pharmacokinetics-Ae
Time Frame: up to 24 hours
Urinary excretion rate of M201-A
up to 24 hours

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.
Yuji KUMAGAI

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.
February 17, 2017

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, 2017

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 28, 2017

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).
February 10, 2017

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.
February 13, 2017

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.
February 16, 2017

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.
November 30, 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.
November 28, 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.
November 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-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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