Healthy Volunteers
Conditions
Brief summary
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.
Detailed description
Not Provided
Interventions
DRUGM201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
DRUGPlacebo
Saline Placebo for M201-A Route of administration: continuous intravenous injection
Sponsors
Aetas Pharma Co. Ltd.
Yuji KUMAGAI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
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
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 day8) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics-Tmax | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Time to Cmax (Tmax) of M201-A |
| Pharmacokinetics-AUC0-24 | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Area under the plasma concentration-time curve from time zero to 24hour of M201-A |
| Pharmacokinetics-AUC0-t | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | -Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A |
| Pharmacokinetics-AUC0-∞ | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A |
| Pharmacokinetics-Cmax | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Observed maximum plasma concentration (Cmax) of M201-A |
| Pharmacokinetics-CL | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Apparent clearance of drug from plasma (CL) of M201-A |
| Pharmacokinetics-Vd | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Apparent volume of distribution during the terminal phase (Vd) of M201-A |
| Pharmacokinetics-E0-24 | up to 24 hours | Amount of drug excreted in urine from time zero to 24hour of M201-A |
| Pharmacokinetics-Ae | up to 24 hours | Urinary excretion rate of M201-A |
| Pharmacokinetics-t1/2 | Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A | Elimination half-life (t1/2) of M201-A |
Countries
Japan
Outcome results
None listed