The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT04347005
• Lead Sponsor: Arthrosi Therapeutics

Brief Summary

A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)
• Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
• Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures

Exclusion Criteria

• Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
• History of cardiac abnormalities
• History and/or presence of drug addiction or excessive use of alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings	8 Days	Analysis of abnormal safety laboratory findings
Time to maximum plasma concentration (Tmax) for AR882	6 Days	Profile from plasma in terms of Tmax for AR882
Apparent terminal half-life (t1/2) for AR882	6 Days	Profile from plasma in terms of t1/2 for AR882
Safety Analyses	8 Days	Vital Sign - Respiratory Rate
Area under the curve (AUC) for plasma AR882	6 Days	Profile from plasma in terms of AUC for AR882
Fractional Excretion (FEUA) for AR882	6 Days	Profile from urine in terms of FEUA for AR882
Maximum plasma concentration (Cmax) for AR882	6 Days	Profile from plasma in terms of Cmax for AR882
Amount excreted (Ae) into urine for AR882	6 Days	Profile from urine in terms of Ae for AR882

Secondary Outcome Measures

Name	Time	Method
PD profile of a single dose of AR882 in combination with allopurinol	6 Days	Profile from serum uric acid concentrations over time
PD profile of a single dose of AR882 in combination with febuxostat	6 Days	Profile from serum uric acid concentrations over time
PD profile of a single dose of AR882	6 Days	Profile from serum uric acid concentrations over time

Trial Locations

Locations (1)

Nucleus Network Pty, Ltd.; 🇦🇺 Melbourne, Victoria, Australia