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Study identifier: NCT04236219 Synced from ClinicalTrials.gov · August 11, 2026
● Study status: CompletedSAD

ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers

Condition: Hyperuricemia  ·  Sponsor: Allena Pharmaceuticals

PhasePhase 1
Planned participants24
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersYesCheck eligibility criteria ↓
WhereCincinnati, Ohio, United States
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

Medpace Clinical PharmacologyCincinnati, Ohio, United States

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Cincinnati

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