NCT05256810

A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Dose Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-XDH in Healthy Adult Subjects and Adult Patients With Gout

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Gout

Interventions

Type	Name	Description
DRUG	ALN-XDH	ALN-XDH administered by SC injection
DRUG	Placebo	Placebo administered by SC injection

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2022-02-25
• Last updated: 2024-03-29

Locations

1 site across 1 country: United Kingdom