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

NCT04987242 | Completed Phase 2 FDA Drug

• 1 other identifier: ALLN-346-201
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperuricemia; Gout; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Number of of participants with treatment emergent adverse events

  21 days per Study Part

Secondary Outcomes (1)

• Serum ALLN-346

  8 days

Other Outcomes (1)

• Serum Urate

  8 days

Study Arms (2)

ALLN-346 (Engineered Urate Oxidase)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ALLN-346 DRUG

ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration

Also known as: Engineered urate oxidase

ALLN-346 (Engineered Urate Oxidase)

Placebo DRUG

Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Also known as: Matching placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Allena Pharmaceuticals: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Gout; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• C Tosone, MS, RAC

  Allena Pharmceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study population includes generally healthy subjects with hyperuricemia without CKD, and those with eGFR of mild-moderate CKD. The maximal tolerated dose from the MAD study in normal healthy volunteers (Study 102) will be administered. The study is comprised of two Parts. Under optional Part 2, only subjects with eGFR of CKD Stages 2- 3a.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 3, 2021
• Study Start: July 16, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)