Healthy Volunteers
Conditions
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.
Interventions
DRUGM201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
DRUGPlacebo
Placebo: M201-A Placebo Route of administration: continuous intravenous injection
Sponsors
Aetas Pharma Co. Ltd.
Kitasato University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed