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A Dose Escalation Phase 1 Study Evaluating the Safety and Pharmacokinetics of an Inhaled COVID-19 Inhibitor Delcetravir in Healthy Subjects

COVID-19 Clinical Trial

Official title:
A Single and Multiple Dose Escalation First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Delcetravir Administered Via Inhalation in Healthy Subjects

Clinical Trial Summary

This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects.

Clinical Trial Description

Primary objectives: - To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (18-50 years of age). - To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (50-80 years of age). - To evaluate the pharmacokinetics (PK) of Delcetravir after single and multiple doses of ESFAM289 in healthy subjects (18-50 years of age). - To evaluate the PK of Delcetravir after single and multiple doses of Delcetravir in healthy subjects (50-80 years of age) Secondary objectives: - To compare the PK of Delcetravir after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age). - To compare the safety and tolerability after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05453279
Study type Interventional
Source Esfam Biotech Pty Ltd
Contact Albert G Frauman, MD
Phone +61 416198042
Email albert@esfambiotech.com.au
Status Not yet recruiting
Phase Phase 1
Start date September 1, 2022
Completion date January 1, 2023
View Details
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