Allergic Rhinitis
Conditions
Brief summary
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A.
Interventions
Repeating ascending dose
Repeating ascending dose
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of allergic rhinitis * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs * Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug
Exclusion criteria
* History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders * History of anaphylaxis, hypersensitivity or drug allergies * Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing * Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing * Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results | Throughout study or until early discontinuation |
| Incidence, nature, and severity of adverse events | Throughout study or until early discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life) | Throughout study or until early discontinuation |