A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults

Hoffmann-La Roche0 sites36 target enrollmentNovember 7, 2011

ConditionsHealthy Volunteer

InterventionsPlacebo RO5469754

DrugsPlacebo RO5469754

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 36
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.

Registry

clinicaltrials.gov

Start Date

November 7, 2011

End Date

September 3, 2012

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female volunteers, 18 to 64 years of age, inclusive
•Body mass index (BMI) 18 to 32 kg/m2
•Women of child-bearing potential and their partners must be willing to use two highly effective forms of contraception, one of which must be a barrier method, for the entire duration of the study (through study discharge) or for up to five half-lives after the last dose
•Male subjects with female partners of child-bearing potential must be willing to use a condom during sexual activity for the duration of the study (through study discharge) or for up to five half-lives after the last dose

Exclusion Criteria

•Pregnant or lactating women
•Positive test for drugs of abuse (including ethanol) as per local standards
•Willing to comply with a non-smoking policy during the in-clinic part of the study (Day -1 until discharge on Day 4)
•Positive for hepatitis B, hepatitis C or HIV infection
•History or presence of clinically significant disease or condition
•Participation in an investigational drug or device study within 60 days prior to dosing
•Current (or previous history of) exposure to therapeutic or investigational monoclonal antibody or chimeric biomolecule
•Any confirmed clinically significant previous allergic drug reaction, or history of anaphylaxis