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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005773-68 | EudraCT Number |
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The Sponsor elected not to continue with the study
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The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: ALN-XDH | Experimental | A single dose of ALN-XDH administered by subcutaneous (SC) injection. |
|
| Part A: Placebo | Placebo Comparator | A single dose of placebo administered by SC injection. |
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| Part B: ALN-XDH Single Dose | Experimental | A single dose of ALN-XDH administered by SC injection. |
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| Part B: ALN-XDH Multiple Dose | Experimental | Multiple doses of ALN-XDH administered by SC injection. |
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| Part B: Placebo | Placebo Comparator | Multiple doses of placebo administered by SC injection. |
|
| Part C: ALN-XDH | Experimental | A single dose of ALN-XDH administered by SC injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-XDH | Drug | ALN-XDH administered by SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Frequency of Adverse Events | Up to 10 months | |
| Parts B and C: Frequency of Adverse Events | Up to 14 months | |
| Parts B and C: Percentage of Participants with Serum Uric Acid (sUA) <6 mg/dL | Up to 12.25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-XDH and Potential Metabolites | Day 1 predose and up to 48 hours postdose | |
| Part A: Maximum Plasma Concentration (Cmax) for ALN-XDH and Potential Metabolites | Day 1 predose and up to 48 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41388232 | Derived | 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. |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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|
| Part C: Placebo | Placebo Comparator | A single dose of placebo administered by SC injection. |
|
| Placebo | Drug | Placebo administered by SC injection |
|
| Part A: Time to Maximum Plasma Concentration (tmax) for ALN-XDH and Potential Metabolites | Day 1 predose and up to 48 hours postdose |
| Part A: Fractional Excreted in Urine (fe) for ALN-XDH and Potential Metabolites | Day 1 predose and up to 24 hours postdose |
| Part A: Percent Change from Baseline in sUA | Baseline through Month 9 |
| Parts B and C: Percentage of Participants with sUA <5 mg/dL | Up to 12.25 months |
| Parts B and C: Percentage Change from Baseline in sUA Level | Up to 12.25 months |
| Parts B and C: Plasma Concentrations of ALN-XDH and Potential Major Metabolite(s) | Day 1 and Day 85 predose and up to 4 hours postdose |
| Parts B and C: Frequency of Treatment-associated Gout Flares | Treatment-associated gout flares are defined as gout flares that occur within 6 months of study drug initiation. | Up to 6 months |
| Parts B and C: Percent Change from Baseline in 24-hour Urine Uric Acid (uUA) | Baseline through Month 6 |
| Parts B and C: Percent Change from Baseline in Serum Xanthine | Baseline through Month 6 |
| Parts B and C: Percent Change from Baseline in 24-hour Urine Xanthine | Baseline through Month 6 |
| Parts B and C: Percent Change from Baseline in Serum Hypoxanthine | Baseline through Month 6 |
| Parts B and C: Percent Change from Baseline in 24-hour Urine Hypoxanthine | Baseline through Month 6 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |