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First-in-Patient Study for Sing le Dose of M201-A Hydrochloride Injection in Japanese Patients With Paroxysmal Atrial Fibrillation

NCT04609059 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-10-30

No results posted yet for this study

Summary

First-in-Patient Study for sing le dose of M201-A hydrochloride injection in Japanese patients with paroxysmal atrial fibrillation.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DRUG

M201-A Injection

Active Substance: M201-A Route of administration: continuous intravenous injection Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)

DRUG

Placebo

Saline Placebo: M201-A Placebo Route of administration: continuous intravenous injection Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)

Sponsors & Collaborators

  • Aetas Pharma Co. Ltd.

    collaborator INDUSTRY

  • Kitasato University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2019-10-01
Completion
2020-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04609059 on ClinicalTrials.gov