A Study of MCAF5352A in Healthy Volunteers

NCT01540760 | Completed Phase 1

• 1 other identifier: GA28006
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 5 months

Secondary Outcomes (2)

• Pharmacokinetics: Area under the concentration-time curve

  Pre-dose and 5 time points up to 14 days post-dose

• Immunogenicity: Serum MCAF5252A antibodies

  Days 1, 29, 50, 78, 106 and 134

Study Arms (2)

MCAF5352A

EXPERIMENTAL

Drug: MCAF5352A

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MCAF5352A DRUG

Multiple ascending doses

MCAF5352A

Placebo DRUG

Matching MCAF5352A, multiple doses

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Québec, Quebec, G1P 0A2, Canada

Location

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (1)