Peripheral Vascular DiseasePhase 1NCT03028285
Study of Safety and Tolerability of UNIFUZOL (Solution for Infusions) in Healthy Volunteers
A Phase 1 study testing arginine sodium succinate in people with Peripheral Vascular Disease, run by POLYSAN Scientific & Technological Pharmaceutical Company at 2 sites in Russia.
Trial summary
Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- arginine sodium succinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesRussia
- Study dates
- 15 Jul 2016to 26 Jan 2017
- 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
- Healthy condition, as verified by standard clinical, laboratory and instrumental methods of examination.
- The body mass index (BMI) of 18.5 to 30 and a body weight above 50 kg.
- Signed informed consent.
- For men - consent to use the double-barrier contraceptive method during the course of the study, and for 90 days after the study completion.
- For women - negative pregnancy test, absence of lactation, and consent to use the double-barrier method of contraception during the study and for 90 days after study completion. In the case of hormonal contraceptive use, the intake must be canceled no later than 2 months before the start of the study.
Who cannot join
- Intolerance or hypersensitivity to the components of the study drug.
- Chronic diseases of the cardiovascular, bronchopulmonary (including bronchospastic disease), neuroendocrine system, chronic diseases of the gastrointestinal tract, liver, kidneys, blood, immune system, mental illness or substance abuse, or a history of alcoholism.
- Acute infectious diseases within 4 weeks before the start of the study.
- Any abnormalities of the laboratory findings before inclusion.
- The presence of mental disorders, or the history of mental illness.\
- Intake of medications and/or nutritional supplements for 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or using drugs that have a significant effect on hemodynamics, liver function, etc. (for instance, barbiturates, omeprazole, cimetidine) for 2 months prior to the first dose of study medication. Receiving herbal medicines and herbal supplements during the 28 days before the first dose of study medication.
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- Hormonal methods of contraception with systemic effects (including oral and transdermal contraceptives, injectable progesterone, subcutaneous implants with a progestin intrauterine device with progesterone release) and hormone replacement therapy within 60 days prior to the first dose of study medication.
- The injection of any drug, depot (slow release) or the use of drug implant within 3 months prior to the administration of the study drug.
- Abnormalities of vital signs: systolic blood pressure below 100 mm Hg or higher than 130 mm Hg; diastolic blood pressure below 60 mmHg or above 90 mm Hg; heart rate below 60 beats / min or above 90 beats / min.
- Data of 12-lead ECG demonstrating the QTc interval> 450 msec or the QRS> 120 ms on screening visit.
- Blood donation (450 ml of blood or more) in less than 3 months prior to inclusion.
- Participation in clinical trials of drugs in 3 months before inclusion.
- The regular consumption of more than 5 units of alcohol per week (each unit is equal to 30 ml of ethanol or 325 ml of beer) or the history of alcoholism, drug addiction, drug abuse.
- A positive test for alcohol in the exhaled air.
- Smoking more than 10 cigarettes per day.
- A positive urine test for drugs, such as amphetamine, marijuana, morphine, cocaine and methamphetamine, and tricyclic antidepressants, as revealed in urine by immunoassay analysis.
- The positive results of the analyzes for hepatitis B or C, HIV, and/or syphilis.
- Unwilling or unable to give up alcohol intake, smoking and excessive exercise 48 hours prior to study drug administration and up to 96 hours after administration of the drug, as well as food and beverages containing methylxanthines and grapefruit / grapefruit juice from the day prior to the screening visit and at follow-up.
- Compliance to a special diet (eg. vegetarian) or lifestyle (including night work and extreme exercise, such as sports or weight lifting) that may interfere with the study procedures.
- Planning inpatient treatment of the volunteer within one month after the first injection of the study drug.
- Lack of intention to comply with the study regimen.
- Obvious or probable inability of volunteer, according to the judgement of the researcher, to understand and evaluate information about the study and consciously sign the informed consent form, in particular with respect to the expected risks and possible discomfort.
- Expected problem with the placement of venous catheters or performing vein puncture.
- Pregnancy or breast-feeding; unwillingness or inability of a woman of childbearing age to use acceptable methods of barrier contraception, according to the protocol, starting at least 14 days prior to the first dose of study medication and for 90 days after study completion.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Clinical diagnostic laboratory of City Clinical Hospital named after I.V.Davydovsky
Moscow, 109240
Research Center for Eco-safety, Ltd.
Saint Petersburg, 196143
About this study
Official title: Open Randomized Study of the Safety, Tolerability, and Pharmacokinetic Parameters of UNIFUZOL® (Solution for Infusions, 1.4%, Manufactured by "NTFF"POLYSAN " Ltd.,Russia) in Healthy Volunteers at Different Rates of Administration (Phase I)
Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers.
Read the detailed description
Unifuzol, solution for infusions,("NTFF POLYSAN" Ltd., Russia) contains succinic acid and arginine as active ingredients; it has demonstrated cardioprotective, anti-ischemic, endothelial protective and fibrinolytic activity in pre-clinical studies and is considered for clinical trials in peripheral vascular disease.
The primary aim of the present Phase I study is to assess safety and tolerability of Unifusol (1.4% solution for infusions) at different infusion rates in healthy volunteers.
Study objectives:
- Assess the safety parameters (vital signs, the incidence of AEs, SAEs, laboratory abnormalities) during infusion of Unifusol (1.4% solution for infusions) in healthy volunteers at different infusion rates.
- administration of a single infusion of 250 ml at a rate of 3 ml / min.
- administration of a single infusion of 250 ml at a rate of 4.5 ml / min
- administration of a single infusion of 500 ml at a rate of 4.5 ml / min
- Study the pharmacokinetics parameters of the active components of the Unifusol (succinic acid and arginine) in healthy volunteers after single infusion at a dose of 250 ml at a rate of 4.5 ml / min.
Study methods:
- Determination of pharmacokinetic parameters of succinic acid administered at a single Unifusol infusion dose 250 ml at a rate of 4.5 ml / min (AUC, Cmax, Tmax, T1 / 2);
- Determination of pharmacokinetic parameters of arginine after a single Unifusol infusion at a dose 250 ml at a rate of 4.5 ml / min (AUC, Cmax, Tmax, T1 / 2);
- Determination of individual variations of the pharmacokinetic parameters of succinic acid and arginine in healthy volunteers;
- Identification of significant gender differences in the pharmacokinetics of the active ingredients of Unifusol (succinic acid and arginine) in healthy volunteers;
- Determination of the number of compartments in the pharmacokinetic model which will be most appropriate to the measured concentrations after a single infusion (single-chamber, two-chamber or three-chamber pharmacokinetic model).
- Conditions
- Peripheral Vascular Disease
- Being tested
- arginine sodium succinate
- Keywords
- succinate, arginine, vasodilation, peripheral vascular disease
- Medical subject headings
- Peripheral Vascular Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arginine sodium succinateDrug
Also called Unifusol
Healthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at 3 different combinations of dose and infusion rate under the close monitoring of vital signs and other safety parameters.
| Study group | Role | What they receive |
|---|---|---|
| Unifusol 250 ml IV, 3 ml/mil | Experimental | Twelve healthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at a dose 250 ml and infusion rate 3 ml/min. Receives: Drug: arginine sodium succinate |
| Unifusol 250 ml IV, 4.5 ml/min | Experimental | Twenty-four healthy volunteers will receive arginine sodium succinate 1.4% solution (Unifusol) intravenously at a dose 250 ml and infusion rate 4.5 ml/min Receives: Drug: arginine sodium succinate |
| Unifusol 500 ml IV, 4.5 ml/min | Experimental | Twelve healthy volunteers will receive arginine sodium succinate 1.4% solution (Unifusol) intravenously at a dose 500 ml and infusion rate 4.5 ml/min Receives: Drug: arginine sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events, derangements of vital signs, and laboratory abnormalities
Absence of vital disorders, SAEs, laboratory abnormalities, and the incidence of AEs
Measured: 18-26 days
Secondary outcomes (6)
Area under the plasma concentration of arginine versus time curve
AUC
Measured: 6 hours
Area under the plasma concentration of succinic acid versus time curve
AUC
Measured: 6 hours
Peak Plasma Concentration of arginine
Cmax
Measured: 6 hours
Peak Plasma Concentration of succinic acid
Cmax
Measured: 6 hours
Time to peak Plasma Concentration of arginine
Tmax
Measured: 6 hours
Time to peak Plasma Concentration of succinic acid
Tmax
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start15 Jul 2016
- Primary completion19 Jan 2017
- Study completion26 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vasily B Vasilyuk, MD, PhD, Principal investigator, Research Center for Eco-safety
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028285
- Sponsor's protocol ID
- UNI-I-2015
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Study of the Safety, Tolerability, and Pharmacokinetic Parameters of UNIFUZOL® (Solution for Infusions, 1.4%, Manufactured by "NTFF"POLYSAN " Ltd.,Russia) in Healthy Volunteers at Different Rates of Administration (Phase I)
- ClinicalTrials.gov ID
- NCT03028285
- Acronym / sponsor ID
- UNI-I-2015
- Conditions
- Peripheral Vascular Disease
- Keywords
- succinate, arginine, vasodilation, peripheral vascular disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers.
Detailed description
Unifuzol, solution for infusions,("NTFF POLYSAN" Ltd., Russia) contains succinic acid and arginine as active ingredients; it has demonstrated cardioprotective, anti-ischemic, endothelial protective and fibrinolytic activity in pre-clinical studies and is considered for clinical trials in peripheral vascular disease.
The primary aim of the present Phase I study is to assess safety and tolerability of Unifusol (1.4% solution for infusions) at different infusion rates in healthy volunteers.
Study objectives:
- Assess the safety parameters (vital signs, the incidence of AEs, SAEs, laboratory abnormalities) during infusion of Unifusol (1.4% solution for infusions) in healthy volunteers at different infusion rates.
- administration of a single infusion of 250 ml at a rate of 3 ml / min.
- administration of a single infusion of 250 ml at a rate of 4.5 ml / min
- administration of a single infusion of 500 ml at a rate of 4.5 ml / min
- Study the pharmacokinetics parameters of the active components of the Unifusol (succinic acid and arginine) in healthy volunteers after single infusion at a dose of 250 ml at a rate of 4.5 ml / min.
Study methods:
- Determination of pharmacokinetic parameters of succinic acid administered at a single Unifusol infusion dose 250 ml at a rate of 4.5 ml / min (AUC, Cmax, Tmax, T1 / 2);
- Determination of pharmacokinetic parameters of arginine after a single Unifusol infusion at a dose 250 ml at a rate of 4.5 ml / min (AUC, Cmax, Tmax, T1 / 2);
- Determination of individual variations of the pharmacokinetic parameters of succinic acid and arginine in healthy volunteers;
- Identification of significant gender differences in the pharmacokinetics of the active ingredients of Unifusol (succinic acid and arginine) in healthy volunteers;
- Determination of the number of compartments in the pharmacokinetic model which will be most appropriate to the measured concentrations after a single infusion (single-chamber, two-chamber or three-chamber pharmacokinetic model).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unifusol 250 ml IV, 3 ml/mil | Experimental | Drug: arginine sodium succinateTwelve healthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at a dose 250 ml and infusion rate 3 ml/min. |
| Unifusol 250 ml IV, 4.5 ml/min | Experimental | Drug: arginine sodium succinateTwenty-four healthy volunteers will receive arginine sodium succinate 1.4% solution (Unifusol) intravenously at a dose 250 ml and infusion rate 4.5 ml/min |
| Unifusol 500 ml IV, 4.5 ml/min | Experimental | Drug: arginine sodium succinateTwelve healthy volunteers will receive arginine sodium succinate 1.4% solution (Unifusol) intravenously at a dose 500 ml and infusion rate 4.5 ml/min |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy condition, as verified by standard clinical, laboratory and instrumental methods of examination.
- The body mass index (BMI) of 18.5 to 30 and a body weight above 50 kg.
- Signed informed consent.
- For men - consent to use the double-barrier contraceptive method during the course of the study, and for 90 days after the study completion.
- For women - negative pregnancy test, absence of lactation, and consent to use the double-barrier method of contraception during the study and for 90 days after study completion. In the case of hormonal contraceptive use, the intake must be canceled no later than 2 months before the start of the study.
Key exclusion criteria (24 listed)
- Intolerance or hypersensitivity to the components of the study drug.
- Chronic diseases of the cardiovascular, bronchopulmonary (including bronchospastic disease), neuroendocrine system, chronic diseases of the gastrointestinal tract, liver, kidneys, blood, immune system, mental illness or substance abuse, or a history of alcoholism.
- Acute infectious diseases within 4 weeks before the start of the study.
- Any abnormalities of the laboratory findings before inclusion.
- The presence of mental disorders, or the history of mental illness.\
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 |
|---|---|---|
| arginine sodium succinateAlso: UnifusolHealthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at 3 different combinations of dose and infusion rate under the close monitoring of vital signs and other safety parameters. | Drug | Unifusol 250 ml IV, 3 ml/mil, Unifusol 250 ml IV, 4.5 ml/min, Unifusol 500 ml IV, 4.5 ml/min |
Primary outcome
Incidence of treatment-related adverse events, derangements of vital signs, and laboratory abnormalities
Time frame: 18-26 days
Absence of vital disorders, SAEs, laboratory abnormalities, and the incidence of AEs
6 secondary outcomes
Area under the plasma concentration of arginine versus time curve
Time frame: 6 hours
Area under the plasma concentration of succinic acid versus time curve
Time frame: 6 hours
Peak Plasma Concentration of arginine
Time frame: 6 hours
Peak Plasma Concentration of succinic acid
Time frame: 6 hours
Time to peak Plasma Concentration of arginine
Time frame: 6 hours
Time to peak Plasma Concentration of succinic acid
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- 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.
Vasily B Vasilyuk, MD, PhD principal investigator
Research Center for Eco-safety
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing arginine sodium succinate in people with Peripheral Vascular Disease, run by POLYSAN Scientific & Technological Pharmaceutical Company at 2 sites in Russia.
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 5 inclusion and 24 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: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-related adverse events, derangements of vital signs, and laboratory abnormalities (time frame: 18-26 days). 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 Jul 2020.