A Multi-center, Randomized, Observer-blind, Placebo-controlled Safety and Tolerability Study of Repeated Administration of Two Dose Levels of RO4989991 Administered Subcutaneously to Patients With Allergic Rhinitis

Hoffmann-La Roche0 sites24 target enrollmentJuly 2010

ConditionsAsthma

InterventionsRO4989991 Placebo

DrugsPlacebo RO4989991

Overview

Phase: Phase 1
Intervention: RO4989991
Conditions: Asthma
Sponsor: Hoffmann-La Roche
Enrollment: 24
Primary Endpoint: Assessment of the safety and tolerability of RO4989991
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

February 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, 18-65 years of age, inclusively
•A history of allergic rhinitis diagnosed by a physician, but otherwise healthy
•A positive skin prick test to at least one standardized allergen at screening
•A body mass index (BMI) between 18 and 32 kg/m2, inclusively

Exclusion Criteria

•History or presence of any respiratory disease or condition other than allergic rhinitis
•Use of prescription medication or herbal remedies within 14 days of dosing the study drug
•Use of over-the-counter (OTC) medications within 7 days of dosing the study drug
•Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection
•Positive test for human immunodeficiency virus (HIV) or hepatitis B or C