| Trial ID: | L0403 |
| Source ID: | NCT04987242
|
| Associated Drug: |
Alln-346
|
| Title: |
An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperuricemia|Gout|Chronic Kidney Diseases
|
| Interventions: |
DRUG: ALLN-346|DRUG: Placebo
|
| Outcome Measures: |
Primary: Incidence of Treatment Emergent Adverse Events (TEAEs), Number of of participants with treatment emergent adverse events, 21 days per Study Part | Secondary: Serum ALLN-346, Serum concentration of ALLN-346 (ng/mL), 8 days | Other: Serum Urate, Serum urate \[mg/dL\], 8 days
|
| Sponsor/Collaborators: |
Sponsor: Allena Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-07-16
|
| Completion Date: |
2022-03-02
|
| Results First Posted: |
|
| Last Update Posted: |
2023-06-22
|
| Locations: |
Celerion, Tempe, Arizona, 85283, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04987242
|
