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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Incidence of treatment emergent adverse events (TEAEs)
Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 28 days
Anti-drug antibody assessment of immune response
Development of anti-drug antibodies (total Immunoglobin levels, mg/dL)
Time frame: 28 days
Serum level of ALLN-346
Change of serum ALLN-346 level (ng/mL)
Time frame: 48 hours
Serum ALLN-346 uricase activity level
Change of serum ALLN-346 activity (ng/mL)
Time frame: 48 hours
Serum uric acid assessment of pharmacodynamic response
Change in serum uric acid concentration (mg/dL)
Time frame: 48 hours
C-reactive protein (CRP) assessment of inflammation response
Change in CRP blood levels (mg/L)
Time frame: 48 hours
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