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

Phase 1

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: ALLN-346; Drug: Placebo

• Registration Number: NCT04236219
• Lead Sponsor: Allena Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Status Verified: 2020-06
• Study Start: 2020-09-02
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALLN-346	ALLN-346	ALLN-346
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events (TEAEs)	28 days	Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome Measures

Name	Time	Method
C-reactive protein (CRP) assessment of inflammation response	48 hours	Change in CRP blood levels (mg/L)
Anti-drug antibody assessment of immune response	28 days	Development of anti-drug antibodies (total Immunoglobin levels, mg/dL)
Serum uric acid assessment of pharmacodynamic response	48 hours	Change in serum uric acid concentration (mg/dL)
Serum ALLN-346 uricase activity level	48 hours	Change of serum ALLN-346 activity (ng/mL)
Serum level of ALLN-346	48 hours	Change of serum ALLN-346 level (ng/mL)

Trial Locations

Locations (1)

Medpace Clinical Pharmacology; 🇺🇸 Cincinnati, Ohio, United States