A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis. - CS0382-210463
A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of SOL-116 in Healthy Subjects and Patients With Rheumatoid Arthritis
This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a multiple dose part in healthy subjects (Part 3). The study will collect information on pharmacokinetics, safety and tolerability.