Status:
COMPLETED
A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Subject is of Japanese ethnicity
- No evidence of clinically significant respiratory disease
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02213315
Start Date
July 1 2014
End Date
December 1 2014
Last Update
January 9 2015
Active Locations (1)
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1
Research Site
London, United Kingdom