Phase 1 Study of FB1003 Given by Injection to Healthy Adults and Adults with Knee Osteoarthritis Pain to Evaluate Safety, Tolerability, and Drug Effects

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of FB1003, a drug given by subcutaneous injection, in both healthy adults and adults with osteoarthritis OA pain. The study aims to understand blood exposure, concentration, and half-life of FB1003, as well as its effects on disease activity and pain in OA patients. This is a phase 1, randomized, double-blind, placebo-controlled trial sponsored by 4B Technologies Limited. Participants are divided into cohorts receiving single ascending doses SAD or multiple ascending doses MAD of FB1003 or placebo. The trial includes healthy volunteers and adults with knee OA pain who meet specific diagnostic and pain criteria. The dosing is administered under close monitoring, with groups receiving different dose levels in a randomized manner. Throughout the study, participants will undergo blood tests to measure drug levels, immune response, and safety parameters. Assessments include monitoring adverse events, disease activity changes, and pain scores over periods up to 12 or 18 weeks depending on the study part. Researchers will closely observe safety and tolerability from baseline through the study end, with detailed follow-up visits and laboratory tests.

A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects