NCT05197179

A Bridging Study of FB2001 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FB2001 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing.

Detailed description

Coronaviruses belong to the genus of coronavirus of the family coronaviruses. The viruses of the coronavirus genus are positive-sense single-stranded RNA viruses with envelopes, which are approximately 80-160 nm in diameter. Their genetic material is the largest among all RNA viruses and can infect both humans and animals. Coronaviruses can cause respiratory, intestinal, hepatic, and nervous system diseases of different severities. A total of 7 coronaviruses have been found, in which HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 mainly lead to mild and self-limiting upper respiratory tract infections in infected humans, such as common cold; two new types of β-coronaviruses have emerged in the past 12 years, namely severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV), and these two viruses can cause severe human diseases. In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This study is a randomized, double-blinded, placebo-controlled, ascending dose to evaluate the pharmacokinetics, safety and tolerability of FB2001 for injection afer a single and multiple dose administrations in healthy subjects. A total of 40 healthy subjects are planned to be enrolled. Each group will include 8 subjects.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	FB2001	Subjects will be administered with FB2001 by intravenous (IV) infusion
OTHER	FB2001 placebo	Subjects will be administered with FB2001 by intravenous (IV) infusion

Timeline

• Start date: 2021-12-29
• Primary completion: 2022-04-27
• Completion: 2022-06-02
• First posted: 2022-01-19
• Last updated: 2022-07-06

Locations

1 site across 1 country: China