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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperuricemia, Gout, Chronic Kidney Diseases

In brief

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

Key facts

Study ID

NCT04987242

Run by

Allena Pharmaceuticals

People needed

16

Starts

2021-07-16

Expected to finish

2022-03-02

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Screening eGFR of <60 mL/minute/1.73 m2 for Part 1, and for Part 2 Screening eGFR outside the range of 45-100 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

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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