An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)

• Status: Recruiting
• Trial end date: 2022-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allena Pharmaceuticals
• Treatments: Rasburicase

Criteria

Inclusion Criteria:

• Male or female, age 18 to 55 years

• sUA level ≥ 6.8 mg/dL at Screening (hyperuricemia), with or without a diagnosis of gout

• Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation

• Normal non-clinically significant abnormalities in vital signs

• Normal clinical laboratory test results and ECG, which are not considered to be clinically significant

Exclusion Criteria:

• Screening eGFR of <60 mL/minute/1.73 m2

• History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, urological, or psychiatric disorders.

• Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines

• Currently taking any urate-lowering medication within 4 weeks prior to Day 1 (first dosing day)

• Prior uricase therapy or exposure to recombinant uricase

• Clinically significant abnormal findings on electrocardiogram (ECG)

• Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody

• Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening

• Prior dosing in ALLN-346 clinical study

• Per Investigator judgment, is not an ideal clinical study candidate