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Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04314986
Enrollment
30
Registered
2020-03-19
Start date
2019-06-28
Completion date
2019-09-18
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

A study to assess multiple ascending doses of AR882 in healthy adult males.

Interventions

DRUGCohort 1: AR882 or placebo

AR882 or matching placebo administered once daily for 10 days

DRUGCohort 2: AR882 or placebo

AR882 or matching placebo administered once daily for 10 days.

DRUGCohort 3: AR882 or placebo

AR882 or matching placebo administered once daily for 10 days

DRUGCohort 4: AR882 or placebo

AR882 or matching placebo administered once daily for 10 days

Sponsors

Arthrosi Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and \< 9 mg/dL (535 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

Design outcomes

Primary

MeasureTime frameDescription
Fractional Excretion (FEUA) for AR88215 DaysProfile from urine in terms of FEUA following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of adverse events22 DaysIncidence of adverse events following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings22 DaysIncidence of abnormal laboratory findings following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings22 DaysIncidence of abnormal electrocardiogram findings following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings22 DaysIncidence of abnormal vital signs findings following multiple doses of AR882
Area under the curve (AUC) for plasma AR88215 DaysProfile from plasma in terms of AUC following multiple doses of AR882
Time to maximum plasma concentration (Tmax) for AR88215 DaysProfile from plasma in terms of Tmax following multiple doses of AR882
Maximum plasma concentration (Cmax) for AR88215 DaysProfile from plasma in terms of Cmax following multiple doses of AR882
Apparent terminal half-life (t1/2) for AR88215 DaysProfile from plasma in terms of t1/2 following multiple doses of AR882
Amount excreted (Ae) into urine for AR88215 DaysProfile from urine in terms of Ae following multiple doses of AR882

Secondary

MeasureTime frameDescription
PD profile following multiple doses of AR88215 DaysProfile from serum uric acid concentrations over time

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026