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OpenTrials
Completed

NCT Number: NCT01540760

A Study of 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Québec, Quebec, G1P 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCAF5352A

Drug

Multiple ascending doses

Placebo

Drug

Matching MCAF5352A, multiple doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 5 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 29, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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