Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Completed · Phase 1 · Has a placebo group
Conditions studied: Hyperuricemia, Gout
In brief
The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design. ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.
Key facts
- Study ID
- NCT04829435
- Run by
- Allena Pharmaceuticals
- People needed
- 18
- Starts
- 2021-04-21
- Expected to finish
- 2021-06-01
- Last updated by the study team
- 2021-07-01
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, age 18 to 55 years
- 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
You may not qualify if…
- 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, or positive COVID-19 test
- 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
- Prior dosing in ALLN-346 clinical study
- Per Investigator judgment, is not an ideal clinical study candidate
Where it is running
- Medpace Clinical Pharmacology — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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