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An Open-label Study of the Safety and Pharmacokinetics of the TGKP

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

Official title:
An Open-label Study of the Safety and Pharmacokinetics of the Glycolic Acid Tetrasubstituted Piceatannol (TGKP, "Study Drug") With a Single Intravenous Administration With Participation of Healthy Volunteers: 3 Arms With Dose Escalation

Clinical Trial 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 escalation (0.03 mg/kg, 0.06 mg/kg and 0.12 mg/kg). Before administration the study drug will be dosed and diluted in 200 ml of isotonic solution of 0.9% sodium chloride, and then will be administered once intravenously via infusion. During the entire follow-up period, the effect of the study drug on vital signs, instrumental and laboratory data, the development, severity and association of adverse events with the study drug will be monitored, investigated and studied.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06127381
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact
Status Not yet recruiting
Phase Phase 1
Start date November 2023
Completion date April 2024
View Details
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