Status:
UNKNOWN
An Open-label Study of the Safety and Pharmacokinetics of the TGKP
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions:
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the trial is to study the tolerability, safety and pharmacokinetics of the study drug with participation of healthy volunteers after single intravenous administration with dose escalati...
Eligibility Criteria
Inclusion
- Written informed consent to participate in the study;
- Men and women aged 18 to 45;
- Healthy volunteers according to the results of a medical examination: no history, as well as according to a screening examination, of pathologies from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which may affect the safety of the volunteer and the assessment of the results of the study (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant abnormalities);
- Body mass index from 19 to 30;
- Negative test result for HIV, hepatitis, syphilis;
- Negative test for the presence of narcotic and psychostimulant drugs in the urine;
- Negative alcohol test;
- Negative pregnancy test (for women of childbearing age);
- Indicators of general and biochemical blood tests at screening within 1.1 x (upper limit of the reference interval) - 0.9 x (lower limit of the reference interval);
- Consent to the use of barrier contraception methods by the volunteer and his partner during the study period and for 3 months after it.
Exclusion
- A volunteer may terminate his participation in the study at any stage of its implementation. The principal investigator may remove a volunteer from the study at any time in the following cases:
- The researcher decided that the volunteer must be excluded in the interests of the volunteer himself.
- The volunteer is uncooperative or undisciplined.
- The volunteer was included in violation of the rules of the Protocol.
- The volunteer needs additional treatment.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06127381
Start Date
November 1 2023
End Date
April 1 2024
Last Update
November 14 2023
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