Study of Safety and Tolerability of UNIFUZOL (Solution for Infusions) in Healthy Volunteers

NCT03028285 | Completed Phase 1

• 1 other identifier: UNI-I-2015
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Vascular Disease

Keywords

succinate; arginine; vasodilation; peripheral vascular disease

Outcome Measures

Primary Outcomes (1)

• 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

  18-26 days

Secondary Outcomes (6)

• Area under the plasma concentration of arginine versus time curve

  6 hours

• Area under the plasma concentration of succinic acid versus time curve

  6 hours

• Peak Plasma Concentration of arginine

  6 hours

• Peak Plasma Concentration of succinic acid

  6 hours

• Time to peak Plasma Concentration of arginine

  6 hours

Study Arms (3)

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.

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

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

Drug: arginine sodium succinate

Interventions

arginine sodium succinate DRUG

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.

Also known as: Unifusol

Unifusol 250 ml IV, 3 ml/mil; Unifusol 250 ml IV, 4.5 ml/min; Unifusol 500 ml IV, 4.5 ml/min

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (2)

Clinical diagnostic laboratory of City Clinical Hospital named after I.V.Davydovsky

Moscow, 109240, Russia

Location

Research Center for Eco-safety, Ltd.

Saint Petersburg, 196143, Russia

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vasily B Vasilyuk, MD, PhD

  Research Center for Eco-safety

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 23, 2017
• Study Start: July 15, 2016
• Primary Completion: January 19, 2017
• Study Completion: January 26, 2017
• Last Updated: July 14, 2020

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)