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

NCT01160861 | Completed Phase 1

• 1 other identifier: MOP4840g
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results

  Throughout study or until early discontinuation

• Incidence, nature, and severity of adverse events

  Throughout study or until early discontinuation

Secondary Outcomes (1)

• Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)

  Throughout study or until early discontinuation

Study Arms (3)

A

EXPERIMENTAL

Drug: MEMP1972A; Drug: placebo

B

EXPERIMENTAL

Drug: MEMP1972A; Drug: placebo

C

EXPERIMENTAL

Drug: MEMP1972A; Drug: placebo

Interventions

MEMP1972A DRUG

Repeating ascending dose

A; B; C

placebo DRUG

Repeating ascending dose

A; B; C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (1)

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

  PMID: 24990880 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jeffrey Harris, M.D., Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: July 11, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 12, 2022

Record last verified: 2022-12