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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06127381
• Other study ID #: 01-TGKP-2023
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of AE	Occurrence of adverse events (AE)	Within 28 days after administration of the drug
Primary	Occurrence of SAEs	Occurrence of serious adverse events (SAEs)	Within 28 days after administration of the drug