Safety and Efficacy Study of Intramuscular Uricase-PEG 20

EnzymeRx

Status and phase

Unknown

Phase 1

Conditions

Hyperuricemia

Gout

Treatments

Biological: Uricase-PEG 20

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038947

ENZ-102

Details and patient eligibility

About

The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20

Full description

Uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. Because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. In those which chronically elevated uric acid, gout may develop. In the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. Uricase-PEG 20 is a recombinant uricase conjugated with multiple PEG molecules designed to prolong the half-life and decrease the immunogenicity of uricase. This study will characterize the safety, pharmacokinetics and pharmacodynamics of intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout.

Enrollment

28 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Serum uric acid > 6 mg/dL (men) or > 5 mg/dL (women)
Clinical laboratory values within normal limits or not clinically significant
Women should be menopausal or peri-menopausal

Exclusion criteria

Prior exposure to uricase
History of severe allergic reactions, or any allergy to PEG or pegylated products
G6PD or catalase deficiency
Medical condition that may interfere with ability to complete the study (e.g., uncontrolled diabetes or hypertension, congestive heart failure NYHA Class III or IV, history of myocardial infarction, immunosuppression, pregnancy)