Acute Respiratory Distress Syndrome (ARDS)Phase 1NCT06127381
An Open-label Study of the Safety and Pharmacokinetics of the TGKP
A Phase 1 study testing Glycolic acid tetrasubstituted piceatannol (TGKP) in people with Acute Respiratory Distress Syndrome (ARDS), run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Glycolic acid tetrasubstituted piceatannol (TGKP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent to participate in the study;
- Men and women aged 18 to 45;
- 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);
- Body mass index from 19 to 30;
- Negative test result for HIV, hepatitis, syphilis;
- Negative test for the presence of narcotic and psychostimulant drugs in the urine;
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- Negative alcohol test;
- Negative pregnancy test (for women of childbearing age);
- 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);
- Consent to the use of barrier contraception methods by the volunteer and his partner during the study period and for 3 months after it.
Who cannot join
- 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:
- The researcher decided that the volunteer must be excluded in the interests of the volunteer himself.
- The volunteer is uncooperative or undisciplined.
- The volunteer was included in violation of the rules of the Protocol.
- The volunteer needs additional treatment.
About this study
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
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.
- Being tested
- Glycolic acid tetrasubstituted piceatannol (TGKP)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Glycolic acid tetrasubstituted piceatannol (TGKP) |
| 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. Receives: Drug: Glycolic acid tetrasubstituted piceatannol (TGKP) |
| 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. Receives: Drug: Glycolic acid tetrasubstituted piceatannol (TGKP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of AE
Occurrence of adverse events (AE)
Measured: Within 28 days after administration of the drug
Occurrence of SAEs
Occurrence of serious adverse events (SAEs)
Measured: Within 28 days after administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127381
- Sponsor's protocol ID
- 01-TGKP-2023
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06127381
- Acronym / sponsor ID
- 01-TGKP-2023
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1/4 therapeutic dose (TGKP) | Experimental | Drug: Glycolic acid tetrasubstituted piceatannol (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. |
| 1/2 therapeutic dose (TGKP) | Experimental | Drug: Glycolic acid tetrasubstituted piceatannol (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. |
| Full therapeutic dose (TGKP) | Experimental | Drug: Glycolic acid tetrasubstituted piceatannol (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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written informed consent to participate in the study;
- Men and women aged 18 to 45;
- 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);
- Body mass index from 19 to 30;
- Negative test result for HIV, hepatitis, syphilis;
Key exclusion criteria (5 listed)
- 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:
- The researcher decided that the volunteer must be excluded in the interests of the volunteer himself.
- The volunteer is uncooperative or undisciplined.
- The volunteer was included in violation of the rules of the Protocol.
- The volunteer needs additional treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 1/2 therapeutic dose (TGKP), 1/4 therapeutic dose (TGKP), Full therapeutic dose (TGKP) |
Primary outcome
Occurrence of AE
Time frame: Within 28 days after administration of the drug
Occurrence of adverse events (AE)
Occurrence of SAEs
Time frame: Within 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycolic acid tetrasubstituted piceatannol (TGKP) in people with Acute Respiratory Distress Syndrome (ARDS), run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of AE (time frame: Within 28 days after administration of the drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.