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

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

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.

Study Overview

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

Detailed Description

This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study of orally administered ALLN-346. The study will evaluate the safety and tolerability, inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up Period through Day 28 following dosing.

• Study Type: Interventional
• Enrollment (Actual): 24
• 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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
• 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

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
Placebo Comparator: Placebo	Drug: Placebo; 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.; Other Names: Matching placebo capsule
Experimental: ALLN-346	Drug: ALLN-346; 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.; Other Names: Engineered urate oxidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-drug antibody assessment of immune response	Development of anti-drug antibodies (total Immunoglobin levels, mg/dL)	28 days
Serum level of ALLN-346	Change of serum ALLN-346 level (ng/mL)	48 hours
Serum ALLN-346 uricase activity level	Change of serum ALLN-346 activity (ng/mL)	48 hours
Serum uric acid assessment of pharmacodynamic response	Change in serum uric acid concentration (mg/dL)	48 hours
C-reactive protein (CRP) assessment of inflammation response	Change in CRP blood levels (mg/L)	48 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: uric acid; gout; hyperuricemia; urate oxidase
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Antirheumatic Agents; Gout Suppressants; Rasburicase
• Other Study ID Numbers: ALLN-346-101

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