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

Allena Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Hyperuricemia

Treatments

Drug: ALLN-346

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04236219

ALLN-346-101

Details and patient eligibility

About

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.

Full description

This is a Phase I, randomized, double-blind, placebo-controlled single ascending dose study of orally administered ALLN-346. The study will evaluate the safety and tolerability, inflammation and immunogenicity, pharmacokinetics and pharmacodynamics of ALLN-346 in healthy volunteers. The study consists of a Screening Period, a Treatment Period of 3 days, which includes 1 single day of dosing and 3 days of in-house observation, and a safety Follow-up Period through Day 28 following dosing.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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