Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase) (MAD)
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|ClinicalTrials.gov Identifier: NCT04829435|
Recruitment Status : Completed
First Posted : April 2, 2021
Last Update Posted : July 1, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperuricemia Gout||Drug: ALLN-346 Drug: Placebo||Phase 1|
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 pharmacology unit (CPU). Two sequential cohorts will be dosed and followed for safety through Day 28.
The study will evaluate safety and tolerability (including inflammation and immunogenicity), and pharmacodynamics of ALLN-346.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase I Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)|
|Actual Study Start Date :||April 21, 2021|
|Actual Primary Completion Date :||June 1, 2021|
|Actual Study Completion Date :||June 1, 2021|
Experimental: ALLN-346 (Engineered Urate Oxidase)
ALLN-346 is novel urate oxidase provided as capsules for oral administration. Two ascending dose cohorts: Cohort A (3 capsules thrice daily (TID) for a total of 9 capsules per day) and Cohort B (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days for each cohort.
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; It is a proprietary enzyme designed to degrade urate in the intestinal tract
Other Name: Engineered urate oxidase
Placebo Comparator: Placebo
Matching placebo capsules for oral administration. Two ascending dose cohorts: Cohort A (3 capsules thrice daily (TID) for a total of 9 capsules per day) and Cohort B (5 capsules thrice daily (TID) for a total of 15 capsules per day) will be evaluated for 7 days for each cohort.
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Other Name: Matching placebo capsule
- Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 28 days ]Number of of participants with treatment emergent adverse events
- Serum ALLN-346 [ Time Frame: 8 days ]Change of serum concentration of ALLN-346 (ng/mL) and uricase activity (mU/mL)
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
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): NCT04829435
|United States, Ohio|
|Medpace Clinical Pharmacology|
|Cincinnati, Ohio, United States, 45227|
|Study Director:||Christine Tosone, MS, RAC||Allena Pharmaceuticals, Inc.|
|Responsible Party:||Allena Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||April 2, 2021 Key Record Dates|
|Last Update Posted:||July 1, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|