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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01160861
First received: July 9, 2010
Last updated: January 2, 2012
Last verified: January 2012
History of Changes

July 9, 2010
January 2, 2012
July 2010
April 2011   (final data collection date for primary outcome measure)
  • Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01160861 on ClinicalTrials.gov Archive Site
Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life) [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: MEMP1972A
    Repeating ascending dose
  • Drug: placebo
    Repeating ascending dose
  • Experimental: A
    Interventions:
    • Drug: MEMP1972A
    • Drug: placebo
  • Experimental: B
    Interventions:
    • Drug: MEMP1972A
    • Drug: placebo
  • Experimental: C
    Interventions:
    • Drug: MEMP1972A
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01160861
MOP4840g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Jeffrey Harris, M.D., Ph.D. Genentech
Genentech
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP