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已发表论文
ABP-671 单次和多次口服剂量在健康受试者和高尿酸血症受试者中的安全性、耐受性、药代动力学、药效学及食物影响研究
Authors Gurwith M, Wu RJ, Schwertschlag U, Jin AW, Shi D
Received 15 July 2025
Accepted for publication 29 October 2025
Published 28 November 2025 Volume 2025:19 Pages 10607—10620
DOI https://doi.org/10.2147/DDDT.S553918
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Anastasios Lymperopoulos
Marc Gurwith, Roy J Wu, Ullrich Schwertschlag, Adam W Jin, Dongfang Shi
Atom Therapeutics Co., Ltd, Hangzhou, Zhejiang, 310018, People’s Republic of China
Correspondence: Dongfang Shi, Email williamshi3777@atombp.com Marc Gurwith, Email marc.gurwith@atombp.com
Purpose: To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and food effects of single and multiple oral doses of ABP-671, a novel URAT1 inhibitor, in healthy and hyperuricemic subjects.
Patients and Methods: This placebo-controlled study of ABP-671 was conducted in the United States, and contained three parts: a. single ascending dose (SAD); b. multiple ascending dose (MAD); c. food effect. The study doses of SAD part, 0.1, 0.5, and 1.0 mg, and placebo oral solutions were investigated in healthy volunteers. In the MAD study, hyperuricemic but otherwise healthy subjects received 0.2, 0.5, or 1.0 mg/d of ABP-671 or placebo oral solutions for 10 days. In the food effect study, healthy subjects received 1.0 mg ABP-671 tablet in the fasted or fed state in a crossover design.
Results: A total of 24, 27, and 12 subjects were enrolled, with 5, 9, and 5 treatment-emergent adverse events (TEAEs) observed in the SAD, MAD, and food effect studies, respectively. There were no serious adverse events (SAEs) or TEAEs leading to discontinuation or death. In the SAD and MAD studies, the peak plasma concentration and areas under the curves increased with the increasing drug doses. The serum uric acid (sUA) levels started decreasing 3 hours after ABP-671 administration, and the percentage changes from baseline for sUA increased with the increasing drug doses. Fasting or postprandial state did not affect the PK of ABP-671.
Conclusion: Single or multiple oral doses of ABP-671 are well tolerated at doses 0.1, 0.5 and 1.0 mg for the SAD, 0.2, 0.5, and 1.0 mg/d for the MAD, and 1.0 mg for the food effect study. A proportional relationship between dose and exposure was observed. ABP-671 reduced the sUA levels with a rapid (3 hours) onset and in a dose responsive manner.
Keywords: ABP-671, safety, pharmacokinetics, pharmacodynamics, food effect, hyperuricemia, serum uric acid
Atom Therapeutics Co., Ltd, Hangzhou, Zhejiang, 310018, People’s Republic of China
Correspondence: Dongfang Shi, Email williamshi3777@atombp.com Marc Gurwith, Email marc.gurwith@atombp.com
Purpose: To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and food effects of single and multiple oral doses of ABP-671, a novel URAT1 inhibitor, in healthy and hyperuricemic subjects.
Patients and Methods: This placebo-controlled study of ABP-671 was conducted in the United States, and contained three parts: a. single ascending dose (SAD); b. multiple ascending dose (MAD); c. food effect. The study doses of SAD part, 0.1, 0.5, and 1.0 mg, and placebo oral solutions were investigated in healthy volunteers. In the MAD study, hyperuricemic but otherwise healthy subjects received 0.2, 0.5, or 1.0 mg/d of ABP-671 or placebo oral solutions for 10 days. In the food effect study, healthy subjects received 1.0 mg ABP-671 tablet in the fasted or fed state in a crossover design.
Results: A total of 24, 27, and 12 subjects were enrolled, with 5, 9, and 5 treatment-emergent adverse events (TEAEs) observed in the SAD, MAD, and food effect studies, respectively. There were no serious adverse events (SAEs) or TEAEs leading to discontinuation or death. In the SAD and MAD studies, the peak plasma concentration and areas under the curves increased with the increasing drug doses. The serum uric acid (sUA) levels started decreasing 3 hours after ABP-671 administration, and the percentage changes from baseline for sUA increased with the increasing drug doses. Fasting or postprandial state did not affect the PK of ABP-671.
Conclusion: Single or multiple oral doses of ABP-671 are well tolerated at doses 0.1, 0.5 and 1.0 mg for the SAD, 0.2, 0.5, and 1.0 mg/d for the MAD, and 1.0 mg for the food effect study. A proportional relationship between dose and exposure was observed. ABP-671 reduced the sUA levels with a rapid (3 hours) onset and in a dose responsive manner.
Keywords: ABP-671, safety, pharmacokinetics, pharmacodynamics, food effect, hyperuricemia, serum uric acid