Overview

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

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Criteria
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