Clinical trial NCT03055403: First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Kitasato University
Sponsor class: OTHER
Collaborators: name: Aetas Pharma Co. Ltd.
First posted: 2017-02-16
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Throughout the study duration (up to day8)
Secondary outcomes:
measure: Pharmacokinetics-Cmax
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-Tmax
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-AUC0-24
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-AUC0-t
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-AUC0-∞
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-t1/2
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-CL
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-Vd
timeFrame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A
measure: Pharmacokinetics-E0-24
timeFrame: up to 24 hours
measure: Pharmacokinetics-Ae
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Sagamihara
country: Japan
facility: Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE
state: Kanagawa
Study officials:
References: