Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: M201-A InjectionDrug: Placebo
- Registration Number
- NCT04464681
- Lead Sponsor
- Kitasato University
- Brief Summary
This Phase I is designed to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of M201-A administered by multiple continuous intravenous injection in Healthy Japanese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study
- (1)Japanese Healthy Male subjects
- (2)Age 20 to less than 50 years of age
- (3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination
- (4)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:
- (1)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
- (2)Past medical history of cancer, cerebral infarction or cardiac infarction
- (3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation.
- (4)Presence or past history of epilepsy.
- (5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
- (6)heart rate(HR) >= 100 bpm at the screening examination
- (7)The corrected QT interval(QTcF) >= 440 ms at the screening examination
- (8)brain natriuretic peptide(BNP) > 40 pg/mL at the screening examination
- (9)K<3.6 mEq/L at the screening examination
- (10)Past history or suspect of aldosteronism.
- (11)Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
- (12)Cre>1.10 mg/dL, <0.85 mg/dL at the screening examination
- (13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL of 200 mL / blood component donation within 4weeks prior to the first administration.
- (14)Use of prescription drug, over-the-counter medications (except eye drops for dryness, sanitizer for preventing infection), or herbal medication within 4 weeks prior to study medication.
- (15)Subject who consumed furanocoumarin containing food within 7 days prior to study medication.
- (16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to study medication.
- (17)Subject who was administered of another investigational drug within16 weeks prior to agree to participate in this study.
- (18)Subject who was administered M201-A in the past.
- (19)Subject who smoke within 90 day prior to study medication or who cannot quit smoking during the study period.
- (20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV) antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test. Subject with positive result in Coronavirus(COVID-19) test at the screening or at the hospitalization.
- (21) Presence or past history of drug/alcohol abuse.
- (22)Subject who do not use medically acceptable contraceptive method until 90 days after the final study drug administration.
- (23)Subject who investigator judges ineligible for other reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description M201-A Injection M201-A Injection Active Substance: M201-A Route of administration: continuous intravenous injection Placebo Placebo Placebo: M201-A Placebo Route of administration: continuous intravenous injection
- Primary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety and tolerability Throughout the study duration up to day 11 Number of participants with 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trial Center, Department of Research, KITASATO UNIVERSITY KITASATO INSTITUTE HOSPITAL
🇯🇵Tokyo, Japan