Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829435
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2021-03-31
Brief Title:
Study 102 Multiple Ascending Dose Study of ALLN-346 Engineered Urate Oxidase
Sponsor:
Allena Pharmaceuticals
Organization:
Allena Pharmaceuticals
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:
None
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?:
None