A Study of MCAF5352A in Healthy Volunteers

A Phase Ib, Single-Center, Randomized, Placebo-Controlled, Double-Blind Multiple Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers

This single-center, randomized, placebo-controlled, double-blind, multiple ascending dose study will evaluate the safety, pharmacokinetics and immunogenicity of MCAF5352A in healthy volunteers. Subjects will be randomized to receive either MCAF5352A or placebo on Days 1, 15 and 29.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: MCAF5352A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1P 0A2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males and females, 18 - 55 years of age
• Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests
• Body weight between 45 kg and 110 kg
• Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug

Exclusion Criteria:

• Pregnant or lactating women
• Positive for hepatitis B, hepatitis C or HIV infection
• History of significant chronic or recurrent infections
• History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug
• History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse
• Subjects who have previously received the study drug
• Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching MCAF5352A, multiple doses
Experimental: MCAF5352A	Drug: MCAF5352A; Multiple ascending doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	approximately 5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Area under the concentration-time curve	Pre-dose and 5 time points up to 14 days post-dose
Immunogenicity: Serum MCAF5252A antibodies	Days 1, 29, 50, 78, 106 and 134

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

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

• Other Study ID Numbers: GA28006