A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 9, 2015
January 1, 2015
5 months
August 7, 2014
January 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK profile of mavrilimumab
•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 Outcomes (1)
To evaluate the safety of mavrilimumab
from dosing to day 85
Study Arms (3)
100mg arm
EXPERIMENTAL100mg dose
150mg arm
EXPERIMENTAL150mg dose
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Subject is of Japanese ethnicity
- No evidence of clinically significant respiratory disease
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (1)
Research Site
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
malcolm Boyce, BSc MB ChB FRCP FFPM
Hammersmith Medicines Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 9, 2015
Record last verified: 2015-01