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

NCT ID: NCT04236219

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2020-11-06

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.

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.

Conditions

Hyperuricemia

Study Design

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

Study Groups

ALLN-346

ALLN-346

Group Type: EXPERIMENTAL

ALLN-346

Intervention Type: 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.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Engineered urate oxidase; Matching placebo capsule

Eligibility Criteria

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

• 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

Role: STUDY_DIRECTOR

Allena Pharmaceuticals, Inc

Locations

Medpace Clinical Pharmacology

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

ALLN-346-101

Identifier Type: -

Identifier Source: org_study_id