Clinical trial NCT04236219: ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperuricemia
Keywords: hyperuricemia
gout
urate oxidase
uric acid
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: 28 days
Secondary outcomes:
measure: Anti-drug antibody assessment of immune response
timeFrame: 28 days
measure: Serum level of ALLN-346
timeFrame: 48 hours
measure: Serum ALLN-346 uricase activity level
timeFrame: 48 hours
measure: Serum uric acid assessment of pharmacodynamic response
timeFrame: 48 hours
measure: C-reactive protein (CRP) assessment of inflammation response
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology
state: Ohio
Study officials:
affiliation: Allena Pharmaceuticals, Inc
name: Christine Tosone, MS
role: STUDY_DIRECTOR
References: