Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Tuesday that that the first participant has been dosed in the Phase 1 clinical trial of IBI3011, an anti-human Interleukin 1 receptor accessory protein (IL-1RAP) monoclonal antibody.

The single ascending dose (SAD) study is intended to assess the safety, tolerability, and pharmacokinetics of IBI3011 for the first-in-human administration, to support its subsequent clinical development. A total of 40 healthy volunteers and 24 patients with gout flares are planned to be enrolled.

IBI3011 is the first anti-IL-1RAP monoclonal antibody in China intended to address inflammatory and autoimmune diseases. Preclinical data indicate that IBI3011 can significantly suppress gout flares in models of acute gouty arthritis, demonstrating its clinical potential.

Innovent is also planning to initiate a Phase 3 trial of IBI128 (tigulixostat) in gout patients with hyperuricemia.