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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: Drug: Glycolic acid tetrasubstituted piceatannol (TGKP)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Written informed consent to participate in the study;
2. Men and women aged 18 to 45;
3. 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);
4. Body mass index from 19 to 30;
5. Negative test result for HIV, hepatitis, syphilis;
6. Negative test for the presence of narcotic and psychostimulant drugs in the urine;
7. Negative alcohol test;
8. Negative pregnancy test (for women of childbearing age);
9. 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);
10. 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 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:

1. The researcher decided that the volunteer must be excluded in the interests of the volunteer himself.
2. The volunteer is uncooperative or undisciplined.
3. The volunteer was included in violation of the rules of the Protocol.
4. The volunteer needs additional treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1/4 therapeutic dose (TGKP); 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.	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.
Experimental: 1/2 therapeutic dose (TGKP); 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.	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.
Experimental: Full therapeutic dose (TGKP); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Dermatologic Agents; Keratolytic Agents; Glycolic acid
• Other Study ID Numbers: 01-TGKP-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No