Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.
Not Applicable
Not yet recruiting
- Conditions
- Safety and Pharmacokinetics
- Interventions
- Drug: ¼ of the full (target) dose (solution, 5 ml)Drug: ½ of the full (target) dose (solution, 10 ml)Drug: full dose (solution, 20 ml)Drug: 1 ½ of the full (target) dose (solution, 30 ml)Drug: 2 full doses (solution, 40 ml)Drug: course administration of the selected doseOther: Placebo
- Registration Number
- NCT07184606
- Lead Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Brief Summary
A two-stage placebo-controlled open-label safety and pharmacokinetics study of the drug Fluorothiazinone, a concentrate for the preparation of an infusion solution, with participation of adult healthy volunteers.
Stage 1 - single administration; dose escalation will be carried out in sequential groups after evaluation of side effects data on day 7.
Stage 2 - course administration of the selected dose.
Total number of healthy replacement volunteers: 5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ¼ of the full (target) dose (solution, 5 ml) ¼ of the full (target) dose (solution, 5 ml) 1. st cohort of volunteers: 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug. ½ of the full (target) dose (solution, 10 ml) ½ of the full (target) dose (solution, 10 ml) 1. st cohort of volunteers: 3 healthy volunteers will receive ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ½ of the full (target) dose of the study drug. ½ of the full (target) dose (solution, 10 ml) Placebo 1. st cohort of volunteers: 3 healthy volunteers will receive ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ½ of the full (target) dose of the study drug. ¼ of the full (target) dose (solution, 5 ml) Placebo 1. st cohort of volunteers: 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive ¼ of the full (target) dose of the study drug. full dose (solution, 20 ml) full dose (solution, 20 ml) 1. st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug. full dose (solution, 20 ml) Placebo 1. st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug. 1 ½ of the full (target) dose (solution, 30 ml) 1 ½ of the full (target) dose (solution, 30 ml) 1. st cohort of volunteers: 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug. 1 ½ of the full (target) dose (solution, 30 ml) Placebo 1. st cohort of volunteers: 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 1 ½ of the full (target) dose of the study drug. 2 full doses (solution, 40 ml) 2 full doses (solution, 40 ml) 1. st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) doses of the study drug. 2 full doses (solution, 40 ml) Placebo 1. st cohort of volunteers: 3 healthy volunteers will receive 2 full (target) doses of the study drug, and 1 healthy volunteer will receive placebo. 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) doses of the study drug. course administration of the selected dose course administration of the selected dose 10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo course administration of the selected dose Placebo 10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo
- Primary Outcome Measures
Name Time Method Occurrence of adverse events (AE) within 7 days after administration of the study drug Occurrence of adverse events (AE) according to CTCAE, v.5.0 (Common Terminology Criteria for Adverse Events).
- Secondary Outcome Measures
Name Time Method