A Phase Ia, Single-Center, Randomized, Placebo-Controlled, Double-Blind, Single Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers

Genentech, Inc.0 sites23 target enrollmentDecember 2011

ConditionsHealthy Volunteer

InterventionsMCAF5352A Placebo

DrugsMCAF5352A Placebo

Overview

Phase: Phase 1
Intervention: MCAF5352A
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Enrollment: 23
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study site in Canada.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

June 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Total body weight between 45 and 110 kg
•Vital signs within the following ranges: oral body temperature of 35°C to 37.5°C, systolic blood pressure of 90 to 140 mmHg, diastolic blood pressure of 50 to 90 mmHg, and pulse rate of 45 to 100 bpm
•Laboratory test parameters within normal reference ranges of the safety laboratory
•Female subjects: Willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug. Reliable forms of contraception include oral hormonal contraceptives, patch hormonal contraceptives, vaginal ring, intrauterine device, physical double-barrier methods, surgical hysterectomy, or vasectomy by male partner.

Exclusion Criteria

•Pregnant or lactating women
•Administration of a live, attenuated vaccine within 30 days before Day 1 or anticipation that such a live attenuated vaccine will be required within 100 days of Day 1
•Subjects may receive influenza vaccination only during influenza season (approximately October to March). Subjects must not receive live attenuated influenza vaccine within 30 days prior to Day 1 or at any time during the study.
•Any major illness within 30 days prior to Day 1
•Clinically significant illness requiring treatment within 14 days prior to Day 1
•History of clinically significant ECG abnormalities or a known family history of cardiac conduction system disease
•Positive test results indicating current or past infection with human immunodeficiency virus (HIV-1 or 2), hepatitis B virus (hepatitis B surface antigen \[HBsAg\], hepatitis B core antibody \[anti-HBc\]), or hepatitis C virus (HCV)
•Positive screening test for latent mycobacterial infection within the 2 months preceding Day 1 without evidence of a completed course of anti-tubercular therapy or previous BCG vaccination
•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

Arms & Interventions

A

Intervention: MCAF5352A

B

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: up to approximately 100 days

Secondary Outcomes

Pharmacokinetic: apparent clearance (CL/F)(up to approximately 100 days)
Pharmacokinetic: maximum serum concentration (Cmax)(up to approximately 100 days)
Pharmacokinetic: Terminal half-life (t½)(up to approximately 100 days)
Pharmacokinetic: time to maximum serum concentration (tmax)(up to approximately 100 days)