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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:8/3/2016
Start Date:April 2015
End Date:July 2015

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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

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