Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT05483504
Brief Summary:
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
Study:
NCT05483504
Study Brief:
Protocol Section:
NCT05483504