A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
NCT05256810 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2024-03-29
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 efficacy of ALN-XDH as monotherapy in adult patients with gout
* Part C: Evaluate the safety, tolerability and efficacy of ALN-XDH as add-on therapy in adult patients with gout
Conditions
Interventions
- DRUG
-
ALN-XDH
ALN-XDH administered by SC injection
- DRUG
-
Placebo administered by SC injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Alnylam Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-25
- Primary Completion
- 2023-01-25
- Completion
- 2023-01-25
Countries
- United Kingdom
Study Locations
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