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Completed

NCT Number: NCT03055403

First-in-Human Dose Escalation Study 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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE

Sagamihara, Kanagawa, 252-0375, Japan

About this study

Not Provided

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M201-A Injection

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Pharmacokinetics-E0-24

    Time frame: up to 24 hours

    Amount of drug excreted in urine from time zero to 24hour of M201-A

  10. Pharmacokinetics-Ae

    Time frame: up to 24 hours

    Urinary excretion rate of M201-A

Sponsors and collaborators

Lead sponsor

Yuji KUMAGAI

Other

Collaborators

  • Aetas Pharma Co. Ltd.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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