Back to results

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

Primary Purpose

Hyperuricemia, Gout

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ALLN-346

Placebo

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medpace Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALLN-346 (Engineered Urate Oxidase)

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events (TEAEs)

Number of of participants with treatment emergent adverse events

Secondary Outcome Measures

Serum ALLN-346

Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)

Full Information

NCT ID

NCT04829435

First Posted

March 31, 2021

Last Updated

June 29, 2021

Sponsor

Allena Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04829435

Brief Title

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

Acronym

MAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

April 21, 2021 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allena Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperuricemia, Gout

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALLN-346 (Engineered Urate Oxidase)

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

ALLN-346

Other Intervention Name(s)

Engineered urate oxidase

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Matching placebo capsule

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Treatment Emergent Adverse Events (TEAEs)

Description

Number of of participants with treatment emergent adverse events

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Serum ALLN-346

Description

Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)

Time Frame

8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Tosone, MS, RAC

Organizational Affiliation

Allena Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Medpace Clinical Pharmacology

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs