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Completed

NCT Number: NCT05208996

The siCoV/KK46 Drug Open-safety Study

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

NRC Institute of Immunology FMBA

Moscow, 115478, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Adverse Events

  2. Vital Signs

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Blood pressure in mm Hg

  3. Body Temperature control

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Taking an Axillary Temperature

  4. Heart rate

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Heart Rate in beats per minute

  5. Clinical Chemistry to asses Potassium level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Potassium level in blood

  6. Clinical Chemistry to asses Sodium level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Sodium level in blood

  7. Clinical Chemistry to asses Chloride level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Chloride level in blood

  8. Clinical Chemistry to asses Bicarbonate level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Bicarbonate level in blood

  9. Clinical Chemistry to asses Calcium level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Calcium level in blood

  10. Clinical Chemistry to asses Phosphate level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Phosphate level in blood

  11. Clinical Chemistry to asses Creatine phosphokinase level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Creatine phosphokinase level in blood

  12. Clinical Chemistry to asses Blood urea nitrogen level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Blood urea nitrogen level

  13. Clinical Chemistry to asses Albumin level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Albumin level in blood

  14. Clinical Chemistry to asses Protein level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Protein level in blood

  15. Clinical Chemistry to asses Aspartate transaminase level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Aspartate transaminase level in blood

  16. Clinical Chemistry to asses Alanine transaminase level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Alanine transaminase level in blood

  17. Clinical Chemistry to asses Alkaline phosphatase level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Alkaline phosphatase level in blood

  18. Clinical Chemistry to asses Bilirubin level

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Bilirubin level in blood

  19. Blood Glucose Test

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Measurement of Glucose level

  20. Haematology blood test

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Qualitative and quantitative composition of the cellular components of the blood

  21. Urinalysis

    Time frame: Within 72 hours after single treatment with siCoV/KK46

    Physical, chemical, and microscopic examination of urine

  22. 12-Lead Electrocardiogram

    Time frame: Within 72 hours after single treatment with siCoV/KK46

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2022
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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