NCT05483504

Clinical Study of F61 Injection in Healthy Chinese Subjects

Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Immunogenicity of F61 Injection After a Single Dose in Healthy Chinese Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wuhan Institute of Biological Products Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	F61 injection	Colorless or slightly yellow liquid, may be slightly opalescent
DRUG	F61 Placebo	Colorless or slightly yellow liquid, may be slightly opalescent

Timeline

• Start date: 2022-08-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2022-08-02
• Last updated: 2022-08-02