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

NCT ID: NCT03055403

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2017-11-28

Brief Summary

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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

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Not Provided

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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M201-A Injection

Active Substance: M201-A Route of administration: continuous intravenous injection

Group Type EXPERIMENTAL

M201-A Injection

Intervention Type DRUG

Active Substance: M201-A Route of administration: continuous intravenous injection

Placebo

Saline Placebo for M201-A Route of administration: continuous intravenous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline Placebo for M201-A Route of administration: continuous intravenous injection

Interventions

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M201-A Injection

Active Substance: M201-A Route of administration: continuous intravenous injection

Intervention Type DRUG

Placebo

Saline Placebo for M201-A Route of administration: continuous intravenous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aetas Pharma Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Yuji KUMAGAI

OTHER

Sponsor Role lead

Responsible Party

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Yuji KUMAGAI

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE

Sagamihara, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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M201-A-CT-001

Identifier Type: -

Identifier Source: org_study_id