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Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.

ConditionSafety and Pharmacokinetics
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written Informed Consent to participate in the Study.

The ability to understand the requirements for the study participants, and the willingness to follow the procedures provided in the Study Protocol.

Men and women, age limits: min.: 18, max.: 45.

Healthy according to the results of a medical examination: no history of pathology in the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, or blood, which may affect the safety of the volunteer and the assessment of the Study results (no diseases or clinically significant abnormalities were revealed by clinical, instrumental, and laboratory tests).

Disqualifiers

Volunteer who does not meet the inclusion criteria and meets at least one exclusion criteria was included in the Study by mistake.

Severe violation of the Protocol. The volunteer ignored the Protocol requirements, or the volunteer obtained at least one exclusion criteria during participation in the Study, and further participation causes a risk to the volunteer's health.

Follow-up of the volunteer is not possible. The volunteer did not show up for another visit, any attempts to contact the volunteer were unsuccessful. All attempts to contact a volunteer should be documented.

Voluntary withdrawal from the Study. A volunteer has the right to withdraw from the Study at any time without providing any reasons. If the volunteer provides such reason, it must be registered with the Case Report Form (CRF).

Trial design

Design model

Sequential

Treatments tested in this trial

  • ¼ of the full (target) dose (solution, 5 ml)

    Drug

    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 (parenteral administration). 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 (parenteral administration).

  • ½ of the full (target) dose (solution, 10 ml)

    Drug

    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 (parenteral administration). 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 (parenteral administration).

  • full dose (solution, 20 ml)

    Drug

    1. st cohort of volunteers: 3 healthy volunteers will receive full (target) dose of the study drug, and 1 healthy volunteer will receive placebo (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive full (target) dose of the study drug (parenteral administration).

  • 1 ½ of the full (target) dose (solution, 30 ml)

    Drug

    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 (parenteral administration). 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 (parenteral administration).

  • 2 full doses (solution, 40 ml)

    Drug

    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 (parenteral administration). 2. nd cohort of volunteers: in case of AE in 1st cohort, 3 healthy volunteers will receive 2 full (target) dose of the study drug (parenteral administration).

  • course administration of the selected dose

    Drug

    10 healthy volunteers will receive course administration of the selected dose, and 1 healthy volunteer will receive placebo.

  • Placebo

    Other intervention

    1 healthy volunteer from the 1st cohort of each group will receive placebo (parenteral administration)

Treatment groups

70 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ¼ of the full (target) dose (solution, 5 ml)Experimental treatment 2 interventions
Group B: ½ of the full (target) dose (solution, 10 ml)Experimental treatment 2 interventions
Group C: full dose (solution, 20 ml)Experimental treatment 2 interventions
Group D: 1 ½ of the full (target) dose (solution, 30 ml)Experimental treatment 2 interventions
Group E: 2 full doses (solution, 40 ml)Experimental treatment 2 interventions
Group F: course administration of the selected doseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of adverse events (AE)

Occurrence of adverse events (AE) according to CTCAE, v.5.0 (Common Terminology Criteria for Adverse Events).

Time frame
within 7 days after administration of the study drug

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: