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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Crenezumab

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
  • Texas
    • Dallas, Texas, United States, 75247

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crenezumab Formulation 2; A single dose given as two subcutaneous injections on Day 1	Drug: Crenezumab; Other Names: RO5490245 or MABT5102A (formerly)
Experimental: Crenezumab Formulation 3; A single dose given as two subcutaneous injections on Day 1	Drug: Crenezumab; Other Names: RO5490245 or MABT5102A (formerly)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: GP29172