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

Gout Clinical Trial

— MAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829435
• Other study ID #: ALLN-346-102
• Status: Completed
• Phase: Phase 1
• Start date: April 21, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2021
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• ALLN-346
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
• Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)	Number of of participants with treatment emergent adverse events	28 days
Secondary	Serum ALLN-346	Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)	8 days