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

NCT06127381 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-11-14

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Interventions

DRUG

Glycolic acid tetrasubstituted piceatannol (TGKP)

A total of 25 volunteers will be randomized and receive the study drug, of which 5 - will receive ¼ therapeutic dose, 5 - will receive ½ therapeutic dose, 15 - will receive the full therapeutic dose.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-04-30
Completion
2024-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127381 on ClinicalTrials.gov