A Study of MCAF5352A in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: MCAF5352A; Drug: Placebo

• Registration Number: NCT01540760
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• Study Start: 2012-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCAF5352A	MCAF5352A	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 5 months

Secondary Outcome Measures

Name	Time	Method
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