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RO7303509 is a high-affinity, TGFβ3-specific, humanized immunoglobulin G1 (IgG1) monoclonal antibody developed as a potential anti-fibrotic therapy. It is being investigated primarily for the treatment of systemic sclerosis and other fibrotic diseases. The drug acts by selectively inhibiting transforming growth factor beta 3 (TGFβ3), a cytokine implicated in fibrosis. Preclinical studies demonstrated that RO7303509 can inhibit activation of TGFβ target genes in models of fibrotic lung disease. Clinical trials have shown that single intravenous or subcutaneous doses up to 1200 mg are well tolerated in healthy volunteers, with dose-proportional pharmacokinetics and no serious adverse events reported[3][6]. The drug is administered as a subcutaneous injection and has been evaluated in both single ascending-dose and multiple ascending-dose studies[1][2][4].
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