A Study of RO4989991 in Patients With Allergic Rhinitis
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Drug: RO4989991Drug: Placebo
- Registration Number
- NCT01152619
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 RO4989991 - 2 RO4989991 - 3 Placebo - 4 Placebo -
- Primary Outcome Measures
Name Time Method Assessment of the safety and tolerability of RO4989991 24 weeks
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetics 24 weeks