A Study of MCAF5352A in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540760
• Other study ID #: GA28006
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: November 1, 2016
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• MCAF5352A
Multiple ascending doses
• Placebo
Matching MCAF5352A, multiple doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 5 months	Yes
Secondary	Pharmacokinetics: Area under the concentration-time curve		Pre-dose and 5 time points up to 14 days post-dose	No
Secondary	Immunogenicity: Serum MCAF5252A antibodies		Days 1, 29, 50, 78, 106 and 134	No