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Clinical Trial Summary

This is an open-label, dose-escalation phase I study to assess the safety and tolerability of siCoV/KK46 in healthy volunteers. The purpose of this study is to determine the maximum daily dose of siCoV/KK46 as a single agent in adult healthy participants. Based on preclinical data from this institution, the investigators hypothesize that SARS-CoV-2 inhibition with siCoV/KK46 could potentially reduce pulmonary inflammation, thereby improving COVID-19 patient outcomes.


Clinical Trial Description

This is an open-label, dose-escalation phase I study to assess the safety and tolerability of single and multiple doses of siCoV/KK46 in healthy male volunteers. This study include 3 cohorts received 3.7 mg, 11.1 mg, 22.2 mg of the siCoV/KK46, respectively, via inhalation route. All subjects will undergo scheduled safety and tolerability assessments while in the clinical unit and as outpatients to the end of the follow-up period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05208996
Study type Interventional
Source National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
Contact
Status Completed
Phase Phase 1
Start date January 22, 2021
Completion date March 26, 2021

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