Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Human Monoclonal Antibody TQC2938 Targeting the IL-33/ST2 Axis in Healthy Chinese Adults

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Abstract Background: TQC2938 is a human anti-ST2 monoclonal antibody that targets the IL-33/ST2 axis, which has been found to be involved in regulate both Th2 low and Th2 high immune responses and may be a promising strategy for COPD. TQC2938 is now been investigated in patients with COPD. Objectives: To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of TQC2938 in healthy Chinese adults. Methods: In this phase I randomized, double-blind, placebo-controlled study, single subcutaneous (SC) doses of TQC2938 or placebo were administered to 44 healthy adults (52.5 to 1260 mg). Single intravenous (IV) doses of TQC2938 210mg or placebo were administered to 10 healthy adults (8:2). Thirty adults were randomized 1:1:1 to receive TQC2938 210mg or placebo, 630mg or placebo and 840mg or placebo (8:2) every 28 days for three doses. Safety, tolerability, immunogenicity and pharmacokinetic profiles were analyzed. Results: No deaths, treatment-related serious adverse events, or study discontinuations due to adverse events were reported. All the adverse events (AE) reported were of grade 1 or 2 expect 3 subjects experienced a grade 3. Treatment emergent adverse events occurred at similar rates in different doses of TQC2938. TQC2938 displayed linear pharmacokinetics in healthy adults. Mean T1/2 for both IV and SC administration of TQC2938 ranged from 9.77 to 19.9 days. Conclusions: TQC2938 was well tolerated at all doses administered during the study in healthy Chinese adults. Our results support further clinical development of TQC2938 for COPD and other related diseases mediated by Th2 inflammation.

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