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

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: MEMP1972A; Drug: placebo

• Registration Number: NCT01160861
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study Start: 2010-07-11
• Study First Posted: 2010-07-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	placebo	-
C	placebo	-
B	placebo	-
A	MEMP1972A	-
B	MEMP1972A	-
C	MEMP1972A	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)	Throughout study or until early discontinuation