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

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ClinicalTrials.gov Identifier: NCT02213315
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: 100mg Mavrilimumab Drug: 150mg mavrilimumab Other: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: 100mg arm
100mg dose
Drug: 100mg Mavrilimumab
100mg Mavrilimumab

Experimental: 150mg arm
150mg dose
Drug: 150mg mavrilimumab
150mg mavrilmumab

Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213315


Locations
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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
MedImmune LLC
Investigators
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Principal Investigator: malcolm Boyce, BSc MB ChB FRCP FFPM Hammersmith Medicines Research

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02213315     History of Changes
Other Study ID Numbers: D2190C00016
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by MedImmune LLC:
Healthy Volunteers, Rheumatoid Arthritis, mavrilimumab
Additional relevant MeSH terms:
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Mavrilimumab
Antibodies, Monoclonal
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs