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Main purpose: To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects.
Secondary purpose: To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by single ascending intravenous infusion in healthy subjects.
Research design: This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalating first-in-human Phase I trial to evaluate the tolerability, safety, and pharmacokinetics of F61 injection (F61) in healthy subjects Characteristics and Immunogenicity.
Test drug: F61 injection, specification: 150 mg/5ml/bottle, batch number: 202202002-1, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed.
Control drug: F61 placebo, specification: 5 ml/bottle, produced by Wuhan Institute of Biological Products Co., Ltd.
Validity period: 24 months; Storage conditions: 2~8°C, protected from light and sealed.
No statistical assumptions
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40 participants in 2 patient groups, including a placebo group
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ling gui chen, master
Data sourced from clinicaltrials.gov
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