The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
NCT04347005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2020-11-16
Summary
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Cohort 1: AR882
Single dose of AR882 or matching placebo
- DRUG
-
Cohort 2: AR882
Single dose of AR882 or matching placebo
- DRUG
-
Cohort 3: AR882
Single dose of AR882 or matching placebo
- DRUG
-
Cohort 4: AR882
Single dose of AR882 or matching placebo
- DRUG
-
Cohort 5: AR882
Single dose of AR882 or matching placebo
- DRUG
-
Cohort 6: AR882 Food Effect
Single dose of AR882 or matching placebo in a fed state
- DRUG
-
Cohort 7: AR882 Solid Oral Formulation
Single dose of AR882 or matching placebo
- DRUG
-
Cohort 8: AR882 in combination with allopurinol
Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol
- DRUG
-
Cohort 9: AR882 in combination with febuxostat
Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
Sponsors & Collaborators
-
Arthrosi Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-22
- Primary Completion
- 2019-07-31
- Completion
- 2019-07-31
- FDA Drug
- Yes
Countries
- Australia
Study Locations
More Related Trials
-
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
NCT07116746 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
NCT04155918 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
NCT05253833 ·Status: COMPLETED ·Phase: PHASE2
-
Uric Acid Study in Healthy Male Volunteers
NCT00738842 ·Status: COMPLETED ·Phase: PHASE1
-
A Single Dose Study of SHR4640 in Healthy Male Volunteers
NCT03015948 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
NCT00985127 ·Status: COMPLETED ·Phase: PHASE2
-
Study of of URC102 to Assess the Efficacy and Safety in Gout Patients
NCT04804111 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout
NCT04052932 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
NCT04638543 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion
NCT02752633 ·Status: COMPLETED ·Phase: PHASE4
-
Hyperuricemia and Diabetic Nephropathy
NCT04799925 ·Status: UNKNOWN
-
Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
NCT05513976 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
NCT01399008 ·Status: COMPLETED ·Phase: PHASE2
-
Does Allopurinol Prolong a Treated, Acute Gout Flare?
NCT01988402 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout
NCT00741442 ·Status: COMPLETED ·Phase: PHASE2
-
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
NCT04956432 ·Status: COMPLETED ·Phase: PHASE3
-
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
NCT01416402 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
NCT00663169 ·Status: COMPLETED ·Phase: PHASE2
-
Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level
NCT03211403 ·Status: COMPLETED ·Phase: PHASE1
-
Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
NCT01077284 ·Status: COMPLETED ·Phase: PHASE2
-
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
NCT01508702 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
NCT03906006 ·Status: COMPLETED ·Phase: PHASE1
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
NCT06859073 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of Intramuscular Uricase-PEG 20
NCT01038947 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
NCT03934099 ·Status: COMPLETED ·Phase: PHASE2