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A Study of MCAF5352A in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01540760
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: MCAF5352A Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Study Start Date : March 2012
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: MCAF5352A Drug: MCAF5352A
Multiple ascending doses
Placebo Comparator: Placebo Drug: Placebo
Matching MCAF5352A, multiple doses


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540760


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01540760     History of Changes
Other Study ID Numbers: GA28006
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016