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

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

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
• Actual Primary Completion Date: April 2011
• Actual 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

• 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

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
• First Posted: July 12, 2010
• 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