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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02427243
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 30
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: Crenezumab; Drug: Crenezumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. 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

1. Incidence, nature, and severity of adverse events [Consent through Day 85 or early termination]

2. Incidence of anti-therapeutic antibodies (ATAs) to crenezumab [From Day 1 (Predose) through Day 85 or early termination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Evansville	Indiana	United States	47710
2		Dallas	Texas	United States	75247

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT02427243
• Other Study ID Numbers: GP29172
• First Posted: Apr 27, 2015
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 2, 2016