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
  Purpose

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 Intervention Phase
Allergic Rhinitis
Drug: MEMP1972A
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160861

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01160861     History of Changes
Other Study ID Numbers: MOP4840g
Study First Received: July 9, 2010
Last Updated: January 2, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014