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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01160861
Enrollment
36
Registered
2010-07-12
Start date
2010-07-11
Completion date
2011-04-30
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

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.

Interventions

Repeating ascending dose

DRUGplacebo

Repeating ascending dose

Sponsors

Genentech, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frame
Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test resultsThroughout study or until early discontinuation
Incidence, nature, and severity of adverse eventsThroughout study or until early discontinuation

Secondary

MeasureTime frame
Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)Throughout study or until early discontinuation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026