A Double-blind, Placebo-controlled, Single-dose Study to Evaluate the PK, IM, and Safety in Japanese Subjects
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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.
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History of infection requiring hospitalization or treatment with IV antibiotics within 12 weeks before screening, or evidence of clinically significant active infection.
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Subject has a history or present condition of malignancy.
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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.
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Any blood donation or significant loss of blood within 56 days of study initiation,
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Receipt of live (attenuated) vaccine within the 4 weeks before screening or during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | London | United Kingdom |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Principal Investigator: malcolm Boyce, BSc MB ChB FRCP FFPM, Hammersmith Medicines Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D2190C00016