NCT04829435

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperuricemia
• Gout

Interventions

Type	Name	Description
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
DRUG	Placebo	Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Timeline

• Start date: 2021-04-21
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2021-04-02
• Last updated: 2021-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study