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

NCT ID: NCT04829435

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2021-06-01

Brief Summary

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.

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.

Conditions

Hyperuricemia; Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

ALLN-346

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Engineered urate oxidase; Matching placebo capsule

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allena Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Tosone, MS, RAC

Role: STUDY_DIRECTOR

Allena Pharmaceuticals, Inc.

Locations

Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

ALLN-346-102

Identifier Type: -

Identifier Source: org_study_id