The siCoV/KK46 Drug Open-safety Study

NCT05208996 | Completed Phase 1 DMC

• 1 other identifier: SiCoV/KK46-2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; siRNA; SARS-CoV-2

Outcome Measures

Primary Outcomes (22)

• This is an open-label, dose-escalation phase I study to assess the safety and tolerability of siCoV/KK46 in healthy volunteers

  Adverse Events

  Within 72 hours after single treatment with siCoV/KK46

• Vital Signs

  Blood pressure in mm Hg

  Within 72 hours after single treatment with siCoV/KK46

• Body Temperature control

  Taking an Axillary Temperature

  Within 72 hours after single treatment with siCoV/KK46

• Heart rate

  Heart Rate in beats per minute

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Potassium level

  Measurement of Potassium level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Sodium level

  Measurement of Sodium level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Chloride level

  Measurement of Chloride level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Bicarbonate level

  Measurement of Bicarbonate level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Calcium level

  Measurement of Calcium level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Phosphate level

  Measurement of Phosphate level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Creatine phosphokinase level

  Measurement of Creatine phosphokinase level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Blood urea nitrogen level

  Measurement of Blood urea nitrogen level

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Albumin level

  Measurement of Albumin level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Protein level

  Measurement of Protein level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Aspartate transaminase level

  Measurement of Aspartate transaminase level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Alanine transaminase level

  Measurement of Alanine transaminase level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Alkaline phosphatase level

  Measurement of Alkaline phosphatase level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Clinical Chemistry to asses Bilirubin level

  Measurement of Bilirubin level in blood

  Within 72 hours after single treatment with siCoV/KK46

• Blood Glucose Test

  Measurement of Glucose level

  Within 72 hours after single treatment with siCoV/KK46

• Haematology blood test

  Qualitative and quantitative composition of the cellular components of the blood

  Within 72 hours after single treatment with siCoV/KK46

• Urinalysis

  Physical, chemical, and microscopic examination of urine

  Within 72 hours after single treatment with siCoV/KK46

• 12-Lead Electrocardiogram

  Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings

  Within 72 hours after single treatment with siCoV/KK46

Study Arms (1)

siCoV/KK46

EXPERIMENTAL

Drug contains anti-SARS-CoV-2 siRNAs/KK-46 (peptide dendrimer) complexes for inhalation use

Drug: siCoV/KK46

Interventions

siCoV/KK46 DRUG

The modified phase I "3 + 1+1" study design was used in dose escalation from low dose to high dose to determine the maximum daily dose. Sequential assignment of Patient cohorts to one of three dose levels of inhaled siCoV/KK46: 3.7 mg, 11.1 mg, 22.2 mg.

siCoV/KK46

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men aged 18 to 45 years
• Able to give informed consent and attend all study visits
• Blood pressure level: systolic blood pressure 100 to 139 mm Hg, diastolic blood pressure 60 to 89 mm Hg.
• Heart rate from 60 to 90 beats per minute
• Body mass index 18.5 -30. The body weight should be ≥ 55 kg;
• Men must agree to use the reliable contraception while on study medication and for posttrial contraception for 30 days
• Be able to understand and comply with protocol requirements

You may not qualify if:

• A burdened allergic history.
• Previous adverse reactions to the active substance and/or excipients included in the drug.
• Chronic diseases of the cardiovascular, lymphatic, respiratory, nervous, endocrine, digestive, musculoskeletal, integumentary, immune systems, as well as the genitourinary apparatus and hematopoietic organs.
• Weakness of the inspiratory muscles of respiration (according to spirometry result).
• Acute infectious diseases symptoms in the last 4 weeks before screening.
• Treatment with any medicine that have a pronounced effect on hemodynamics and affects the liver function (barbiturates, omeprazole, cimetidine, etc.) within 2 months prior to screening.
• Regular treatment with any medicine less than 2 weeks prior to screening and single treatment less than 7 days prior screening.
• Donation of blood or plasma less than 3 months prior to screening.
• Transfusion of blood and/or its components less than 3 months prior to screening.
• Participation in other investigational drug or device clinical trials within 90 days prior to screening.
• Smoking more than 10 cigarettes currently, or history of smoking this number of cigarettes within 6 months prior to screening.
• Positive blood tests for HIV, hepatitis B and С, syphilis. Positive PCR test results for SARS-CoV-2(nasal swab).
• Positive result on a urine drug screening test.
• Positive test for ethanol vapor in exhaled air.
• Planned hospitalization during the period of participation in the study, for any reason other than hospitalization specified by this protocol.

Sponsors & Collaborators

• National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia: lead
• St. Petersburg Research Institute of Vaccines and Sera: collaborator

Study Sites (1)

NRC Institute of Immunology FMBA

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Head of Immunopathology Department

Model Details: This is a dose-escalation trial, all participants will receive single or multiple treatment with siCoV/KK46 via an inhaled route. Participants enrolled in this trial may receive one of the following doses: Cohort 1: 3.7 mg; Cohort 2: 11.1 mg; Cohort 3: 22.2 mg

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 26, 2022
• Study Start: January 22, 2021
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

RU (1)