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

January 8, 2015 updated by: MedImmune LLC

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo
Experimental: 100mg arm
100mg dose
Drug: 100mg Mavrilimumab
100mg Mavrilimumab
Experimental: 150mg arm
150mg dose
Drug: 150mg mavrilimumab
150mg mavrilmumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK profile of mavrilimumab
Time Frame: 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
from dosing to day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of mavrilimumab
Time Frame: 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
from dosing to day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Principal Investigator: malcolm Boyce, BSc MB ChB FRCP FFPM, Hammersmith Medicines Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2190C00016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe