First-in-Patient Study for sing le dose of M201-A hydrochloride injection in Japanese patients with paroxysmal atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
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.)
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.)
Koga general Hospital
Koga, Ibaraki, Japan
RECRUITINGKitasato University Hospital
Sagamihara, Kanagawa, Japan
RECRUITINGSendai Cardiovascular Center
Sendai, Miyagi, Japan
Safety Assessment
Safety investigation based on combined Investigator examination, Adverse Events (particulary, incidence of abnormal laboratory tests,abnormal vital sings,abnormal 12-lead ECG, abnormal 24-hour Holter ECG)
Time frame: throughout the study duration(up to day7)
Arrest of atrial fibrillation (AF)
Ratio of arrested AF\* in administered subjects within 2 hours after administration (\*Restoration of sinus rhythm should be kept at least one(1) minute or more.)
Time frame: throughout the study duration(Within 2 hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan
RECRUITINGYamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
RECRUITING