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

Hyperuricemia Clinical Trial

— SAD  

Official title:

A Phase I Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236219
• Other study ID #: ALLN-346-101
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Hyperuricemia

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