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

Hyperuricemia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04236219
Study type Interventional
Source Allena Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date September 2, 2020
Completion date November 6, 2020
View Details
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