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A Study of MCAF5352A in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01540760
First received: February 23, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes

February 23, 2012
March 11, 2013
March 2012
February 2013   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: approximately 5 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01540760 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose and 5 time points up to 14 days post-dose ] [ Designated as safety issue: No ]
  • Immunogenicity: Serum MCAF5252A antibodies [ Time Frame: Days 1, 29, 50, 78, 106 and 134 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy Volunteer
  • Drug: MCAF5352A
    Multiple ascending doses
  • Drug: Placebo
    Matching MCAF5352A, multiple doses
  • Experimental: MCAF5352A
    Intervention: Drug: MCAF5352A
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01540760
GA28006
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP