A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: MEMP1972A
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: MEMP1972A<br>* Repeating ascending dose<br>Drug: placebo<br>* Repeating ascending dose<br>|
| Experimental: B<br> | Drug: MEMP1972A<br>* Repeating ascending dose<br>Drug: placebo<br>* Repeating ascending dose<br>|
| Experimental: C<br> | Drug: MEMP1972A<br>* Repeating ascending dose<br>Drug: placebo<br>* Repeating ascending dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life) |  | Throughout study or until early discontinuation |