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A Study of MCAF5352A in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: February 23, 2012
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Healthy Volunteer Drug: MCAF5352A Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 months ]

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

Enrollment: 23
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCAF5352A Drug: MCAF5352A
Multiple ascending doses
Placebo Comparator: Placebo Drug: Placebo
Matching MCAF5352A, multiple doses


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01540760

Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01540760     History of Changes
Other Study ID Numbers: GA28006
Study First Received: February 23, 2012
Last Updated: November 1, 2016 processed this record on September 21, 2017