The siCoV/KK46 Drug Open-safety Study

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208996
• Other study ID #: SiCoV/KK46-2020
• Status: Completed
• Phase: Phase 1
• Start date: January 22, 2021
• Est. completion date: March 26, 2021

Study information

• Verified date: January 2022
• Source: National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy men aged 18 to 45 years

2. Able to give informed consent and attend all study visits

3. Blood pressure level: systolic blood pressure 100 to 139 mm Hg, diastolic blood pressure 60 to 89 mm Hg.

4. Heart rate from 60 to 90 beats per minute

5. Body mass index 18.5 -30. The body weight should be = 55 kg;

6. Men must agree to use the reliable contraception while on study medication and for posttrial contraception for 30 days

7. Be able to understand and comply with protocol requirements

Exclusion Criteria:

1. A burdened allergic history.

2. Previous adverse reactions to the active substance and/or excipients included in the drug.

3. Chronic diseases of the cardiovascular, lymphatic, respiratory, nervous, endocrine, digestive, musculoskeletal, integumentary, immune systems, as well as the genitourinary apparatus and hematopoietic organs.

4. Weakness of the inspiratory muscles of respiration (according to spirometry result).

5. Acute infectious diseases symptoms in the last 4 weeks before screening.

6. 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.

7. Regular treatment with any medicine less than 2 weeks prior to screening and single treatment less than 7 days prior screening.

8. Donation of blood or plasma less than 3 months prior to screening.

9. Transfusion of blood and/or its components less than 3 months prior to screening.

10. Participation in other investigational drug or device clinical trials within 90 days prior to screening.

11. 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.

12. Smoking more than 10 cigarettes currently, or history of smoking this number of cigarettes within 6 months prior to screening.

13. Positive blood tests for HIV, hepatitis B and ?, syphilis. Positive PCR test results for SARS-CoV-2(nasal swab).

14. Positive result on a urine drug screening test.

15. Positive test for ethanol vapor in exhaled air.

16. Planned hospitalization during the period of participation in the study, for any reason other than hospitalization specified by this protocol.

17. Inability or inability to follow the protocol, to perform the procedures prescribed by the protocol, to follow a diet, activity regime.

18. Any conditions that, according to the researcher's, may be a contraindication to the participation in the study.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• siCoV/KK46
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.

Locations

Country	Name	City	State
Russian Federation	NRC Institute of Immunology FMBA	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia	St. Petersburg Research Institute of Vaccines and Sera

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vital Signs	Blood pressure in mm Hg	Within 72 hours after single treatment with siCoV/KK46
Primary	Body Temperature control	Taking an Axillary Temperature	Within 72 hours after single treatment with siCoV/KK46
Primary	Heart rate	Heart Rate in beats per minute	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Potassium level	Measurement of Potassium level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Sodium level	Measurement of Sodium level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Chloride level	Measurement of Chloride level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Bicarbonate level	Measurement of Bicarbonate level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Calcium level	Measurement of Calcium level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Phosphate level	Measurement of Phosphate level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Creatine phosphokinase level	Measurement of Creatine phosphokinase level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Blood urea nitrogen level	Measurement of Blood urea nitrogen level	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Albumin level	Measurement of Albumin level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Protein level	Measurement of Protein level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Aspartate transaminase level	Measurement of Aspartate transaminase level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Alanine transaminase level	Measurement of Alanine transaminase level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Alkaline phosphatase level	Measurement of Alkaline phosphatase level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Clinical Chemistry to asses Bilirubin level	Measurement of Bilirubin level in blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Blood Glucose Test	Measurement of Glucose level	Within 72 hours after single treatment with siCoV/KK46
Primary	Haematology blood test	Qualitative and quantitative composition of the cellular components of the blood	Within 72 hours after single treatment with siCoV/KK46
Primary	Urinalysis	Physical, chemical, and microscopic examination of urine	Within 72 hours after single treatment with siCoV/KK46
Primary	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