An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)

Study Purpose

The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female, age 18 to 55 years.
  • - sUA level ≥ 6.8 mg/dL at Screening (hyperuricemia), with or without a diagnosis of gout.
  • - Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation.
  • - Normal non-clinically significant abnormalities in vital signs.
  • - Normal clinical laboratory test results and ECG, which are not considered to be clinically significant.

Exclusion Criteria:

  • - Screening eGFR of <60 mL/minute/1.73 m2.
  • - History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, urological, or psychiatric disorders.
  • - Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
  • - Currently taking any urate-lowering medication within 4 weeks prior to Day 1 (first dosing day) - Prior uricase therapy or exposure to recombinant uricase.
  • - Clinically significant abnormal findings 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

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Allena Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

C Tosone, MS, RAC
Principal Investigator Affiliation Allena Pharmceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Hyperuricemia, Gout
Additional Details

This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia. Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts with Part 1 administering the target dose and subject continuing Part 2 to explore a lower dose response. The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.

Arms & Interventions


Experimental: ALLN-346 (Engineered Urate Oxidase)

ALLN-346 is novel urate oxidase provided as capsules for oral administration. Two doses may be evaluated under two Study Parts: Part 1 (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days; Part 2 (3 capsules thrice daily (TID) for a total of 9 capsules per day) will be evaluated for 7 days

Placebo Comparator: Placebo

Matching placebo capsules for oral administration. Two doses may be evaluated under two Study Parts: Part 1 (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days; Part 2 (3 capsules thrice daily (TID) for a total of 9 capsules per day) will be evaluated for 7 days


Drug: - ALLN-346

ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration

Drug: - Placebo

Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Celerion, Tempe, Arizona





Tempe, Arizona, 85283

Site Contact

Danielle Armas, MD

[email protected]