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Clinical Study of F61 Injection in Healthy Chinese Subjects

NCT05483504 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-02

No results posted yet for this study

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

Interventions

DRUG

F61 injection

Colorless or slightly yellow liquid, may be slightly opalescent

DRUG

F61 Placebo

Colorless or slightly yellow liquid, may be slightly opalescent

Sponsors & Collaborators

  • Wuhan Institute of Biological Products Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2022-12-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05483504 on ClinicalTrials.gov