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Innovent Announces First Participant Dosed in a Phase 1 Clinical Trial of IBI3011, a Recombinant Anti-Human Interleukin 1 Receptor Accessory Protein Monoclonal Antibody
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major disease areas, announced that the first participant has been successfully dosed in a Phase 1 clinical trial of IBI3011, an anti-human Interleukin 1 receptor accessory protein (IL-1RAP) monoclonal antibody developed by Innovent.
About this update from Innovent Biologics, Inc.
[{"type":"text","content":"SAN FRANCISCO and SUZHOU, China, Dec. 9, 2025 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major disease areas, announced that the first participant has been successfully dosed in a Phase 1 clinical trial of IBI3011, an anti-human Interleukin 1 receptor accessory protein (IL-1RAP) monoclonal antibody developed by Innovent.","length":563,"tagName":"p"},{"type":"text","content":"This study is a single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of IBI3011 for the first-in-human administration, so as to support the subsequent clinical development of IBI3011. A total of 40 healthy volunteers and 24 patients with gout flares are planned to be enrolled.","length":317,"tagName":"p"},{"type":"text","content":"With economic development and rising living standards, the number of gout patients in China is increasing. By 2019, the estimated number of patients had exceeded 3 million.[1],[2] When serum uric acid rises above its saturation point, urate crystals can deposit in joints, triggering local inflammation and tissue damage and causing gout flares.[3] Recurrent flares can lead to joint destruction and functional impairment, limiting patients' social roles and seriously reducing quality of life.","length":498,"tagName":"p"},{"type":"text","content":"At present, first-line pharmacologic treatments for gout flare mainly consist of nonsteroidal anti-inflammatory drugs and colchicine, to which certain patients have contraindications or cannot tolerate, lacking targeted therapies. Second-line therapies as glucocorticoids are also associated with numerous adverse effects. In addition, only one IL‑1β–targeted agent has been approved in China for the treatment of gout flare, and there remains a large unmet need in clinical practice.","length":484,"tagName":"p"},{"type":"text","content":"IL-1RAP, a member of the IL-1 family, serves as a co-receptor that forms receptor complexes with IL-1R1, ST2, and IL-36R and mediates downstream signaling pathways triggered by IL1α/β, IL33 and IL36, respectively. These cytokines are implicated in a broad spectrum of autoimmune and i...