Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04236219
Other study ID # ALLN-346-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2, 2020
Est. completion date November 6, 2020

Study information

Verified date June 2020
Source Allena Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 6, 2020
Est. primary completion date November 6, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ALLN-346
ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
Placebo
Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.

Locations

Country Name City State
United States Medpace Clinical Pharmacology Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Allena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment emergent adverse events (TEAEs) Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 28 days
Secondary Anti-drug antibody assessment of immune response Development of anti-drug antibodies (total Immunoglobin levels, mg/dL) 28 days
Secondary Serum level of ALLN-346 Change of serum ALLN-346 level (ng/mL) 48 hours
Secondary Serum ALLN-346 uricase activity level Change of serum ALLN-346 activity (ng/mL) 48 hours
Secondary Serum uric acid assessment of pharmacodynamic response Change in serum uric acid concentration (mg/dL) 48 hours
Secondary C-reactive protein (CRP) assessment of inflammation response Change in CRP blood levels (mg/L) 48 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05434858 - Imagery as Biomarker of Gout N/A
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Recruiting NCT05504083 - Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients Phase 2
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Completed NCT00288158 - Primary Prevention of Hypertension in Obese Adolescents Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT06084585 - The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia N/A
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Not yet recruiting NCT04586803 - Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers Phase 1
Not yet recruiting NCT02944214 - Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients N/A
Completed NCT02959918 - Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid Phase 2
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2
Active, not recruiting NCT01021241 - Safety and Efficacy Study of Intravenous Uricase-PEG 20 Phase 1
Completed NCT00756964 - Lowering Serum Uric Acid to Prevent Acute Kidney Injury Phase 2
Terminated NCT00607152 - Rasburicase (Fasturtec) Registration Trial Phase 3
Completed NCT03906006 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects Phase 1