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

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, Inc.:

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 (Adult)
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, 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):

Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlén 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.


Responsible Party:	Genentech, Inc.
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 Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections	Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on September 26, 2016