Hyperuricemia Clinical Trial
— SADOfficial title:
A Phase I Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Verified date | June 2020 |
Source | Allena Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 6, 2020 |
Est. primary completion date | November 6, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Signed informed consent form - Incapable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation - Good general health as determined by medical history and physical examination - Normal clinical laboratory test results and ECG Exclusion Criteria: - Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, psychiatric disease or history of hyperuricemia - Any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines - Positive screen results for drugs of abuse, alcohol, or cotinine or recent history of drug or alcohol abuse - Clinically significant abnormal findings on physical examination, vital signs or on electrocardiogram (ECG) - Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody - Received treatment with or exposure to an Investigational drug or device within 30 days prior to or during Screening - Per Investigator judgment, is not an ideal clinical study candidate |
Country | Name | City | State |
---|---|---|---|
United States | Medpace Clinical Pharmacology | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Allena Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment emergent adverse events (TEAEs) | Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 28 days | |
Secondary | Anti-drug antibody assessment of immune response | Development of anti-drug antibodies (total Immunoglobin levels, mg/dL) | 28 days | |
Secondary | Serum level of ALLN-346 | Change of serum ALLN-346 level (ng/mL) | 48 hours | |
Secondary | Serum ALLN-346 uricase activity level | Change of serum ALLN-346 activity (ng/mL) | 48 hours | |
Secondary | Serum uric acid assessment of pharmacodynamic response | Change in serum uric acid concentration (mg/dL) | 48 hours | |
Secondary | C-reactive protein (CRP) assessment of inflammation response | Change in CRP blood levels (mg/L) | 48 hours |
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