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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/4 therapeutic dose (TGKP) | Experimental | First 5 (five) healthy volunteers will receive (a single intravenous administration) 1/4 therapeutic dose. 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. |
|
| 1/2 therapeutic dose (TGKP) | Experimental | Next 5 (five) healthy volunteers will receive (a single intravenous administration) 1/2 therapeutic dose. 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. |
|
| Full therapeutic dose (TGKP) | Experimental | Next 15 (fifteen) healthy volunteers will receive (a single intravenous administration) the full therapeutic dose. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycolic acid tetrasubstituted piceatannol (TGKP) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of AE | Occurrence of adverse events (AE) | Within 28 days after administration of the drug |
| Occurrence of SAEs | Occurrence of serious adverse events (SAEs) | Within 28 days after administration of the drug |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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