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

An Inpatient, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hyperuricemia; Gout
• Intervention / Treatment: Drug: Placebo; Drug: ALLN-346

Detailed Description

This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia, with subpopulations to include generally healthy hyperuricemic subjects with normal kidney function and those with mild to moderate chronic kidney disease (CKD). Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts. Part 1 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR ≥ 60 mL/minute/1.73 m2 (subjects with eGFR of stage 2 CKD and with normal kidney function). Part 2 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR 45-100 mL/minute/1.73 m2 (eGFR of CKD Stages 2- 3a).

The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALLN-346 (Engineered Urate Oxidase); ALLN-346 is novel urate oxidase provided as capsules for oral administration: 5 capsules thrice daily (TID) for a total of 15 capsules per day will be evaluated for 7 days	Drug: ALLN-346; ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; Other Names: Engineered urate oxidase
Placebo Comparator: Placebo; Matching placebo capsules for oral administration: 5 capsules thrice daily (TID) for a total of 15 capsules per day will be evaluated for 7 days	Drug: Placebo; Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules; Other Names: Matching placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs)	Number of of participants with treatment emergent adverse events	21 days per Study Part

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ALLN-346	Serum concentration of ALLN-346 (ng/mL)	8 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Urate	Serum urate [mg/dL]	8 days

Collaborators and Investigators

• Sponsor: Allena Pharmaceuticals
• Investigators: Study Director: C Tosone, MS, RAC, Allena Pharmceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 2, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Rasburicase
• Other Study ID Numbers: ALLN-346-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No