Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase) (MAD)

A Phase I Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)

The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design.

ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

Study Overview

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

Detailed Description

This is a Phase I, 7-day, randomized, double-blind, placebo-controlled, multiple ascending dose study of orally administered ALLN-346 in normal healthy volunteers. Study will take place at a clinical pharmacology unit (CPU). Two sequential cohorts will be dosed and followed for safety through Day 28.

The study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of ALLN-346.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, age 18 to 55 years
• Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
• Good general health as determined by medical history and physical examination
• Normal clinical laboratory test results and ECG

Exclusion Criteria:

• Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia
• Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
• Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse, or positive COVID-19 test
• Clinically significant abnormal findings on physical examination, vital signs or 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. Two ascending dose cohorts: Cohort A (3 capsules thrice daily (TID) for a total of 9 capsules per day) and Cohort B (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days for each cohort.	Drug: ALLN-346; ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; It is a proprietary enzyme designed to degrade urate in the intestinal tract; Other Names: Engineered urate oxidase
Placebo Comparator: Placebo; Matching placebo capsules for oral administration. Two ascending dose cohorts: Cohort A (3 capsules thrice daily (TID) for a total of 9 capsules per day) and Cohort B (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days for each cohort.	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	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ALLN-346	Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)	8 days

Collaborators and Investigators

• Sponsor: Allena Pharmaceuticals
• Investigators: Study Director: Christine Tosone, MS, RAC, Allena Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Rasburicase
• Other Study ID Numbers: ALLN-346-102

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