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

December 9, 2022 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: MEMP1972A
Repeating ascending dose
Drug: placebo
Repeating ascending dose
Experimental: B
Drug: MEMP1972A
Repeating ascending dose
Drug: placebo
Repeating ascending dose
Experimental: C
Drug: MEMP1972A
Repeating ascending dose
Drug: placebo
Repeating ascending dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time Frame: Throughout study or until early discontinuation
Throughout study or until early discontinuation
Incidence, nature, and severity of adverse events
Time Frame: Throughout study or until early discontinuation
Throughout study or until early discontinuation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Jeffrey Harris, M.D., Ph.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 11, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

July 9, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP4840g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Clinical Trials on MEMP1972A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe