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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Crenezumab

• Registration Number: NCT02427243
• Lead Sponsor: Genentech, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crenezumab Formulation 3	Crenezumab	A single dose given as two subcutaneous injections on Day 1
Crenezumab Formulation 2	Crenezumab	A single dose given as two subcutaneous injections on Day 1

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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