Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05256810
Status:
TERMINATED
Last Update Posted:
2024-03-29
First Post:
2022-02-16
Brief Title:
A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
Sponsor:
Alnylam Pharmaceuticals
Organization:
Alnylam Pharmaceuticals
Study Overview
Official Title:
A Phase 12 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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor elected not to continue with the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005773-68 | EUDRACT_NUMBER | None | None |