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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014