A Phase 1 interventional study of ALLN-346 and Placebo in Hyperuricemia, sponsored by Allena Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by Allena Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
ALLN-346
Drug: ALLN-346
Placebo
Drug: Placebo
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.
Also known as: Engineered urate oxidase
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.
Also known as: Matching placebo capsule
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
Plan to share: No
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Allena Pharmaceuticals