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

Phase 1/2 Terminated 44 enrolled Alnylam Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2022-02-25
Primary completion: 2023-01-25
Completion: 2023-01-25

Outcome

Outcome not reported

Stopped: “The Sponsor elected not to continue with the study”

Publications

Badri P, Kolachana K, Duong A, Lasko M, Nandi T, Mehrotra N, Robbie GJ. Platform Assessment of Concentration-QTc Relationship Across GalNAc-siRNA Molecules. Clin Pharmacokinet. 2026 Feb;65(2):293-311. doi: 10.1007/s40262-025-01606-0. Epub 2025 Dec 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALN-XDH	Small interfering RNA (siRNA)	—	Subcutaneous