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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MEMP1972A
placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    A

    B

    C

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
    Incidence, nature, and severity of adverse events

    Secondary Outcome Measures

    Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)

    Full Information

    First Posted
    July 9, 2010
    Last Updated
    December 9, 2022
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01160861
    Brief Title
    A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 11, 2010 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Title
    B
    Arm Type
    Experimental
    Arm Title
    C
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MEMP1972A
    Intervention Description
    Repeating ascending dose
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Repeating ascending dose
    Primary Outcome Measure Information:
    Title
    Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
    Time Frame
    Throughout study or until early discontinuation
    Title
    Incidence, nature, and severity of adverse events
    Time Frame
    Throughout study or until early discontinuation
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)
    Time Frame
    Throughout study or until early discontinuation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffrey Harris, M.D., Ph.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24990880
    Citation
    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.
    Results Reference
    derived

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

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