A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
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ClinicalTrials.gov Identifier: NCT01160861 |
Recruitment Status :
Completed
First Posted : July 12, 2010
Last Update Posted : January 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis | Drug: MEMP1972A Drug: placebo | Phase 1 |
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 |
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 |
- Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results [ Time Frame: Throughout study or until early discontinuation ]
- Incidence, nature, and severity of adverse events [ Time Frame: Throughout study or until early discontinuation ]
- Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life) [ Time Frame: Throughout study or until early discontinuation ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160861
Study Director: | Jeffrey Harris, M.D., Ph.D. | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01160861 |
Other Study ID Numbers: |
MOP4840g |
First Posted: | July 12, 2010 Key Record Dates |
Last Update Posted: | January 5, 2012 |
Last Verified: | January 2012 |
Rhinitis Rhinitis, Allergic Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |