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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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100mg arm

100mg dose

Group Type EXPERIMENTAL

100mg Mavrilimumab

Intervention Type DRUG

100mg Mavrilimumab

150mg arm

150mg dose

Group Type EXPERIMENTAL

150mg mavrilimumab

Intervention Type DRUG

150mg mavrilmumab

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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100mg Mavrilimumab

Intervention Type DRUG

150mg mavrilimumab

150mg mavrilmumab

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes