First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects

Yuji KUMAGAI

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: M201-A Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03055403

M201-A-CT-001

Details and patient eligibility

About

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.

Full description

Not Provided

Enrollment

40 patients

Sex

Male

Ages

20 to 39 years old

Volunteers

Accepts Healthy Volunteers

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