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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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

Key facts

Study ID

NCT02427243

Run by

Genentech, Inc.

People needed

60

Starts

2015-04-01

Expected to finish

2015-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Evansville, Indiana, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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