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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo; Drug: 100mg Mavrilimumab; Drug: 150mg mavrilimumab

• Registration Number: NCT02213315
• Lead Sponsor: MedImmune LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
100mg arm	100mg Mavrilimumab	100mg dose
150mg arm	150mg mavrilimumab	150mg dose

Primary Outcome Measures

Name	Time	Method
PK profile of mavrilimumab	from dosing to day 85	•Non-compartmental PK parameters following a single-dose of mavrilimumab to analyse •Maximum observed concentration (Cmax); area under the concentration-time curve (AUC); time to maximum concentration (Tmax) and half-life (t1/2) from dosing to Day 85 •The number and percentage of subjects that are ADA positive will be summarized by dose

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of mavrilimumab	from dosing to day 85	•The secondary outcome of the study is the safety of mavrilimumab as measured by the frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) from dosing to day 85

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom