drugset / Trial / NCT05208996
The siCoV/KK46 Drug Open-safety Study
Phase 1
Completed
10 enrolled
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
St. Petersburg Research Institute of Vaccines and Sera · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-01-22
- Primary completion
- 2021-03-26
- Completion
- 2021-03-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | siCoV/KK46 | Small interfering RNA (siRNA) | 3.7 mg | Inhaled |
| Subject | siCoV/KK46 | Small interfering RNA (siRNA) | 11.1 mg | Inhaled |
| Subject | siCoV/KK46 | Small interfering RNA (siRNA) | 22.2 mg | Inhaled |