Status:
TERMINATED
A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Gout
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to: * Part A: Evaluate the safety and tolerability of single ascending doses of ALN-XDH in healthy adult participants * Part B: Evaluate the safety, tolerability and effi...
Eligibility Criteria
Inclusion
- Part A: has serum uric acid (sUA) level ≥4 mg/dL and ≤7 mg/dL
- Parts B and C: meets the American College of Rheumatology criteria for acute arthritis of primary gout
- Part B: has an sUA level ≥8 mg/dL while not receiving urate-lowering therapy (ULT) or following a 1-week washout period of prior ULT
- Part C: has been on a stable dose of allopurinol for gout for ≥6 weeks prior to screening
- Part C: has an sUA level ≥6 mg/dL
Exclusion
- Parts A, B and C: Has received an investigational agent within the last 30 days
- Parts A, B and C: Has experienced or is being treated for acute gout flare(s) within 14 days prior to randomization
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05256810
Start Date
February 25 2022
End Date
January 25 2023
Last Update
March 29 2024
Active Locations (1)
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1
Clinical Trial Site
London, United Kingdom