NCT02427243CompletedPhase 1
A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 60
- Primary Endpoint
- Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)
Study Overview
Brief Summary
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or female 18 to 65 years of age at Screening, inclusive
- •Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive
- •Body weight 50 to 100 kg, inclusive
- •Females must be of non-childbearing potential
- •Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later
Exclusion Criteria
- •Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)
- •History of alcoholism or drug addiction within 6 months prior to CRU Check-in
- •Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in
Arms & Interventions
Crenezumab Formulation 2
Experimental
A single dose given as two subcutaneous injections on Day 1
Intervention: Crenezumab (Drug)
Crenezumab Formulation 3
Experimental
A single dose given as two subcutaneous injections on Day 1
Intervention: Crenezumab (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)
Time Frame: Day 1 through Day 85 or early termination
Secondary Outcomes
- Incidence, nature, and severity of adverse events(Consent through Day 85 or early termination)
- Incidence of anti-therapeutic antibodies (ATAs) to crenezumab(From Day 1 (Predose) through Day 85 or early termination)
Investigators
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