A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
NCT04060173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2020-02-12
Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.
Conditions
- Hyperuricemia
- Gout
Interventions
- DRUG
-
ABP-671
ABP-671 is an investigational drug
- OTHER
-
Placebo
Matching placebo
Sponsors & Collaborators
-
Atom Therapeutics Co., Ltd
lead INDUSTRY
Principal Investigators
-
Danielle Armas, MD · Celerion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-05
- Primary Completion
- 2019-12-29
- Completion
- 2020-02-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Tolerance, Pharmacokinetics / Pharmacodynamics (PK / PD) and Immunogenicity of Pegylated Uric Acid Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers
NCT05226013 ·Status: UNKNOWN ·Phase: PHASE1
-
Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects
NCT04303039 ·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
-
Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
NCT03857165 ·Status: COMPLETED ·Phase: PHASE1
-
Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients
NCT04040816 ·Status: COMPLETED ·Phase: PHASE2
-
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia
NCT03185793 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
NCT07324434 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level
NCT03211403 ·Status: COMPLETED ·Phase: PHASE1
-
Single and Multiple Dose Study in Japanese Subjects
NCT01872832 ·Status: COMPLETED ·Phase: PHASE1
-
Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)
NCT02837198 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
NCT01336686 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Intramuscular Uricase-PEG 20
NCT01038947 ·Status: UNKNOWN ·Phase: PHASE1
-
Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout
NCT01129648 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
NCT07145229 ·Status: RECRUITING ·Phase: PHASE2
-
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
NCT01407874 ·Status: COMPLETED ·Phase: PHASE2
-
Multiple Dose Study of SHR4640 in Healthy Subjects
NCT02890966 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol
NCT01265264 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
NCT00985127 ·Status: COMPLETED ·Phase: PHASE2
-
Study of FYU-981 in Hyperuricemia With or Without Gout
NCT03006445 ·Status: COMPLETED ·Phase: PHASE3
-
A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
NCT06310967 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
NCT03100318 ·Status: COMPLETED ·Phase: PHASE3
-
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
NCT02078219 ·Status: COMPLETED ·Phase: PHASE2
-
Uric Acid Study in Healthy Male Volunteers
NCT00738842 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of Intravenous Uricase-PEG 20
NCT01021241 ·Status: UNKNOWN ·Phase: PHASE1
-
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia
NCT06056570 ·Status: COMPLETED ·Phase: PHASE1/PHASE2