Trial | NCT03055403  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    m201-a ...

  • Study Participants

    40
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.
Not Provided
Study Started
Feb 17
2017
Primary Completion
Nov 28
2017
Study Completion
Nov 28
2017
Last Update
Nov 30
2021

Drug M201-A Injection

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

Drug Placebo

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

M201-A Injection Experimental

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

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted