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: August 4, 2014
Last verified: August 2014
  Purpose

This single-center, randomized, placebo-controlled, double-blind, multiple ascen ding 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01540760

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01540760     History of Changes
Other Study ID Numbers: GA28006
Study First Received: February 23, 2012
Last Updated: August 4, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on August 20, 2014