Healthy Volunteer
Conditions
Brief summary
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
Interventions
DRUGCrenezumab
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2) | Day 1 through Day 85 or early termination |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed