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

NCT ID: NCT01160861

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-11

Study Completion Date

2011-04-30

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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

MEMP1972A

Intervention Type DRUG

Repeating ascending dose

placebo

Intervention Type DRUG

Repeating ascending dose

B

Group Type EXPERIMENTAL

MEMP1972A

Intervention Type DRUG

Repeating ascending dose

placebo

Intervention Type DRUG

Repeating ascending dose

C

Group Type EXPERIMENTAL

MEMP1972A

Intervention Type DRUG

Repeating ascending dose

placebo

Intervention Type DRUG

Repeating ascending dose

Interventions

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MEMP1972A

Repeating ascending dose

Intervention Type DRUG

placebo

Repeating ascending dose

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Harris, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

References

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Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.

Reference Type DERIVED
PMID: 24990880 (View on PubMed)

Other Identifiers

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MOP4840g

Identifier Type: -

Identifier Source: org_study_id