A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Crenezumab

Study type

Interventional

Funder types

Industry

Identifiers

GP29172

Details and patient eligibility

About

To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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