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

NCT04829435 | Completed Phase 1 FDA Drug

• 1 other identifier: ALLN-346-102
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia; Gout

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Number of of participants with treatment emergent adverse events

  28 days

Secondary Outcomes (1)

• Serum ALLN-346

  8 days

Study Arms (2)

ALLN-346 (Engineered Urate Oxidase)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ALLN-346 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

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 - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allena Pharmaceuticals: lead

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

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

Study Officials

• Christine Tosone, MS, RAC

  Allena Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: April 21, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)