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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
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
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of of participants with treatment emergent adverse events
Time frame: 28 days
Serum ALLN-346
Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)
Time frame: 8 days
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