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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04987242
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Allena Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Hyperuricemia Gout Drug: ALLN-346 Drug: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study population includes generally healthy subjects with hyperuricemia. The study is comprised of a planned Part 1, where the maximal tolerated dose from the MAD study in normal healthy volunteers (Study 102) will be administered, and an optional Part 2, which will explore a lower dose. If Part 2 is conducted, subjects from Part 1 will continue in Part 2 under the same treatment group (ALLN-346 or placebo). New subjects may enroll in Part 2 in the case where a Part 1 subject(s) does not continue.
Masking: Double (Participant, Investigator)
Masking Description: Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment.
Primary Purpose: Treatment
Official Title: An Inpatient, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects
Actual Study Start Date : July 16, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout

Arm Intervention/treatment
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
Drug: ALLN-346
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Other Name: Engineered urate oxidase

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: Placebo
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Other Name: Matching placebo capsule




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 21 days per Study Part ]
    Number of of participants with treatment emergent adverse events


Secondary Outcome Measures :
  1. Serum ALLN-346 [ Time Frame: 8 days ]
    Serum concentration of ALLN-346 (ng/mL)


Other Outcome Measures:
  1. Serum Urate [ Time Frame: 8 days ]
    Serum urate [mg/dL]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04987242


Contacts
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Contact: B Kandinov, PhD (617) 467-4577 Clinical346@allenapharma.com

Locations
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United States, Arizona
Celerion Recruiting
Tempe, Arizona, United States, 85283
Contact: Danielle Armas, MD    602-437-0097    danielle.armas@celerion.com   
Sponsors and Collaborators
Allena Pharmaceuticals
Investigators
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Study Director: C Tosone, MS, RAC Allena Pharmceuticals
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Responsible Party: Allena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04987242    
Other Study ID Numbers: ALLN-346-201
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents