Hyperuricemia
Conditions
Keywords
hyperuricemia, gout, urate oxidase, uric acid
Brief summary
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.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study of orally administered ALLN-346. The study will evaluate the safety and tolerability, inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up Period through Day 28 following dosing.
Interventions
DRUGALLN-346
ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
DRUGPlacebo
Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
Sponsors
Allena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | 28 days | Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-drug antibody assessment of immune response | 28 days | Development of anti-drug antibodies (total Immunoglobin levels, mg/dL) |
| Serum level of ALLN-346 | 48 hours | Change of serum ALLN-346 level (ng/mL) |
| Serum ALLN-346 uricase activity level | 48 hours | Change of serum ALLN-346 activity (ng/mL) |
| Serum uric acid assessment of pharmacodynamic response | 48 hours | Change in serum uric acid concentration (mg/dL) |
| C-reactive protein (CRP) assessment of inflammation response | 48 hours | Change in CRP blood levels (mg/L) |
Countries
United States
Outcome results
None listed