ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers

NCT04236219 | Completed Phase 1 FDA Drug

• 1 other identifier: ALLN-346-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.

Conditions

Hyperuricemia

Keywords

hyperuricemia; gout; urate oxidase; uric acid

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events (TEAEs)

  Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  28 days

Secondary Outcomes (5)

• Anti-drug antibody assessment of immune response

  28 days

• Serum level of ALLN-346

  48 hours

• Serum ALLN-346 uricase activity level

  48 hours

• Serum uric acid assessment of pharmacodynamic response

  48 hours

• C-reactive protein (CRP) assessment of inflammation response

  48 hours

Study Arms (2)

ALLN-346

EXPERIMENTAL

ALLN-346

Drug: ALLN-346

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ALLN-346 DRUG

ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.

Also known as: Engineered urate oxidase

ALLN-346

Placebo DRUG

Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.

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:

• Signed informed consent form
• 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
• 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
• 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

  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: January 14, 2020
• First Posted: January 22, 2020
• Study Start: September 2, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: July 23, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)