Status:
COMPLETED
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Lead Sponsor:
Allena Pharmaceuticals
Conditions:
Hyperuricemia
Gout
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 d...
Detailed Description
This is a Phase I, 7-day, randomized, double-blind, placebo-controlled, multiple ascending dose study of orally administered ALLN-346 in normal healthy volunteers. Study will take place at a clinical ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04829435
Start Date
April 21 2021
End Date
June 1 2021
Last Update
July 1 2021
Active Locations (1)
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1
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States, 45227