NCT05583812

A Study of FB2001 for Inhalation in Healthy Chinese Adults

A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 for Inhalation in Healthy Chinese Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

FB2001 is a novel inhalable preparation being developed for COVID-19 treatment. A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of FB2001 in Healthy Chinese Adults

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. This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of FB2001 in healthy adult volunteers.The study aims to evaluate the safety, tolerability and pharmacokinetic profile of FB2001 administered by aerosol inhalation after single and multiple ascending doses.Approximately 32 participants will be sequentially enrolled into either 1 of 2 SAD cohorts (n=8 per cohort), or 1 of 2 MAD cohorts (n= 8 per cohort). An adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
DRUG	FB2001 for inhalation	FB2001 once or twice daily inhalation
DRUG	FB2001 for inhalation placebo	FB2001 placebo once or twice daily inhalation

Timeline

• Start date: 2022-10-21
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-10-18
• Last updated: 2023-01-11

Locations

1 site across 1 country: China