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

Arthrosi Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Cohort 3: AR882; Drug: Cohort 2: AR882; Drug: Cohort 8: AR882 in combination with allopurinol; Drug: Cohort 7: AR882 Solid Oral Formulation; Drug: Cohort 4: AR882; Drug: Cohort 5: AR882; Drug: Cohort 1: AR882; Drug: Cohort 6: AR882 Food Effect; Drug: Cohort 9: AR882 in combination with febuxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT04347005

AR882-101

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 9 patient groups, including a placebo group

AR882 (Dose A)

Experimental group

Treatment:

Drug: Cohort 1: AR882

AR882 (Dose B)

Experimental group

Treatment:

Drug: Cohort 6: AR882 Food Effect

Drug: Cohort 8: AR882 in combination with allopurinol

Drug: Cohort 9: AR882 in combination with febuxostat

Drug: Cohort 2: AR882

AR882 (Dose C)

Experimental group

Treatment:

Drug: Cohort 3: AR882

AR882 (Dose D)

Experimental group

Treatment:

Drug: Cohort 4: AR882

AR882 (Dose E)

Experimental group

Treatment:

Drug: Cohort 5: AR882

AR882 (Dose B) Solid Oral Formulation

Experimental group

Treatment:

Drug: Cohort 7: AR882 Solid Oral Formulation

Placebo

Placebo Comparator group

Treatment:

Drug: Cohort 4: AR882

Drug: Cohort 5: AR882

Drug: Cohort 1: AR882

Drug: Cohort 6: AR882 Food Effect

Drug: Cohort 3: AR882

Drug: Cohort 2: AR882

Drug: Cohort 7: AR882 Solid Oral Formulation

Allopurinol

Active Comparator group

Treatment:

Drug: Cohort 8: AR882 in combination with allopurinol

Febuxostat

Active Comparator group

Treatment:

Drug: Cohort 9: AR882 in combination with febuxostat