NCT01877785CompletedPhase 1
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAA4549A in Healthy Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 21
- Primary Endpoint
- Safety: Incidence of adverse events
Study Overview
Brief Summary
This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- •Weight 40 to 100 kg
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- •Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
- •Volunteers agree to use acceptable contraceptive measures
Exclusion Criteria
- •History or clinically significant manifestations of disorders
- •History of anaphylaxis, hypersensitivity or drug allergies
- •History or presence of an abnormal ECG
- •History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
- •History of significant drug abuse within 1 year prior to screening
- •Current tobacco smokers
- •Positive drug screen at screening or at check-in
- •Positive pregnancy test result at screening or Day -1 or breast feeding during the study
Arms & Interventions
MHAA4549A Arm
Experimental
Intervention: MHAA4549A (Drug)
Placebo Arm
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety: Incidence of adverse events
Time Frame: 120 days
Secondary Outcomes
- Incidence of anti-therapeutic antibodies(120 days)
- Pharmacokinetics: Serum concentration-time profile of MHAA4549A(Pre-dose on day 1 to day 120 post-dose)
Investigators
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