Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allena Pharmaceuticals
• Treatments: Rasburicase

Criteria

Inclusion Criteria:

• 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

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, 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