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The siCoV/KK46 Drug Open-safety Study

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

siCoV/KK46

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, siRNA, SARS-CoV-2

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Drinking of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 mL of beer, 150 mL of wine or 40 mL of strong alcoholic drinks) per week within the last month prior to inclusion in the study and/or history of alcohol, drug or chemical abuse.
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.
Inability or inability to follow the protocol, to perform the procedures prescribed by the protocol, to follow a diet, activity regime.
Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.

Sites / Locations

NRC Institute of Immunology FMBA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

siCoV/KK46

Arm Description

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

Outcomes

Primary Outcome Measures

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

Adverse Events

Vital Signs

Blood pressure in mm Hg

Body Temperature control

Taking an Axillary Temperature

Heart rate

Heart Rate in beats per minute

Clinical Chemistry to asses Potassium level

Measurement of Potassium level in blood

Clinical Chemistry to asses Sodium level

Measurement of Sodium level in blood

Clinical Chemistry to asses Chloride level

Measurement of Chloride level in blood

Clinical Chemistry to asses Bicarbonate level

Measurement of Bicarbonate level in blood

Clinical Chemistry to asses Calcium level

Measurement of Calcium level in blood

Clinical Chemistry to asses Phosphate level

Measurement of Phosphate level in blood

Clinical Chemistry to asses Creatine phosphokinase level

Measurement of Creatine phosphokinase level in blood

Clinical Chemistry to asses Blood urea nitrogen level

Measurement of Blood urea nitrogen level

Clinical Chemistry to asses Albumin level

Measurement of Albumin level in blood

Clinical Chemistry to asses Protein level

Measurement of Protein level in blood

Clinical Chemistry to asses Aspartate transaminase level

Measurement of Aspartate transaminase level in blood

Clinical Chemistry to asses Alanine transaminase level

Measurement of Alanine transaminase level in blood

Clinical Chemistry to asses Alkaline phosphatase level

Measurement of Alkaline phosphatase level in blood

Clinical Chemistry to asses Bilirubin level

Measurement of Bilirubin level in blood

Blood Glucose Test

Measurement of Glucose level

Haematology blood test

Qualitative and quantitative composition of the cellular components of the blood

Urinalysis

Physical, chemical, and microscopic examination of urine

12-Lead Electrocardiogram

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05208996

First Posted

November 30, 2021

Last Updated

January 24, 2022

Sponsor

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

Collaborators

St. Petersburg Research Institute of Vaccines and Sera

1. Study Identification

Unique Protocol Identification Number

NCT05208996

Brief Title

The siCoV/KK46 Drug Open-safety Study

Official Title

An Open-safety Study of the siCoV/KK46 Drug Administered Via an Inhaled Route in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

January 22, 2021 (Actual)

Primary Completion Date

March 26, 2021 (Actual)

Study Completion Date

March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia

Collaborators

St. Petersburg Research Institute of Vaccines and Sera

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, siRNA, SARS-CoV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

siCoV/KK46

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

siCoV/KK46

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Adverse Events

Time Frame