Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT04829435
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Sponsor:
Allena Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase I Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAD
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.
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.
The study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of ALLN-346.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: