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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987242
• Other study ID #: ALLN-346-201
• Status: Completed
• Phase: Phase 2
• Start date: July 16, 2021
• Est. completion date: March 2, 2022

Study information

• Verified date: June 2023
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Gout
• Hyperuricemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
• Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Urate	Serum urate [mg/dL]	8 days
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)	Number of of participants with treatment emergent adverse events	21 days per Study Part
Secondary	Serum ALLN-346	Serum concentration of ALLN-346 (ng/mL)	8 days