Condition: Hyperuricemia · Sponsor: Allena Pharmaceuticals
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.
No contact information is available for this study as per the public registry record.
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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.
| Medpace Clinical Pharmacology | Cincinnati, Ohio, United States | — |
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