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

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2021年1月22日最近更新: 2022年1月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 10
试验地点: 1
主要终点: Body Temperature control

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•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 -
•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

排除标准

•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.

研究组 & 干预措施

siCoV/KK46

Experimental

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

干预措施: siCoV/KK46 (Drug)