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

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ClinicalTrials.gov Identifier: NCT01160861
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: MEMP1972A Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results [ Time Frame: Throughout study or until early discontinuation ]
  2. Incidence, nature, and severity of adverse events [ Time Frame: Throughout study or until early discontinuation ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160861


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Jeffrey Harris, M.D., Ph.D. Genentech, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01160861     History of Changes
Other Study ID Numbers: MOP4840g
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases