A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects

MedImmune

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: 100mg Mavrilimumab

Other: Placebo

Drug: 150mg mavrilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02213315

D2190C00016

Details and patient eligibility

About

A phase 1 randomized, double blind single-dose study to evaluate the PK and immunogenicity of single SC 100 and 150 mg doses of mavrilimumab in healthy adult Japanese subjects.

Full description

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult Japanese subjects. The study will be conducted at one site in Europe and subjects will be randomized in a 5:5:2 ratio to 100, 150mg mavrilimumab and placebo.

Enrollment

39 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is of Japanese ethnicity
No evidence of clinically significant respiratory disease

Exclusion criteria

Any condition that, would interfere with the evaluation of the study drug or safety of subjects.
Subject has a known hypersensitivity to any components of the investigational product.
History of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before screening, or evidence of clinically significant active infection.
Subject has a history or present condition of malignancy.
Subject has a history or presence of drug addiction (urine test) or has alcohol consumption (breath test) of more than 21 (males) or 14 (females) units of alcohol per week.
Any blood donation or significant loss of blood within 56 days of study initiation,
Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.