Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis

Summary

The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are: 1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses. 2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses. 3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis. 4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis. Participants will receive test tablets or placebo at the indicated date and collect blood samples.

Timeline

Start

2021-12-16

Primary completion

2022-02-16

Completion

2023-10-08

Publications

• Zhang H, Li Q, Li C, Wu M, Chen H, Li Y, You F, Zhao Y, Jin J, Chen X, Ding Y. Evaluation of proximod, a selective agonist of sphingosine-1-phosphate receptor-1, in healthy volunteers and patients with rheumatoid arthritis: a phase 1, double-blind, randomised, placebo-controlled, ascending dose trial. Lancet Rheumatol. 2024 Dec;6(12):e837-e847. doi: 10.1016/S2665-9913(24)00199-1. Epub 2024 Oct 22.

Drugs

Indications