Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.

An Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221, Solution for Subcutaneous Administration 1.34 mg/ml (GEROPHARM) and Ozempic®, Solution for Subcutaneous Administration 1.34 mg/ml in Healthy Volunteers

Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Safety Issues; Bioequivalence
• Intervention / Treatment: Drug: GP40221; Drug: ozempic

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Yaroslavl, Russian Federation
    • Yarosslavl Clinical Hospital #3

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Signed informed consent to participate in the study.
• Males with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods.
• Age 18-45 years old inclusive.
• Body mass index 18.5 - 29.9 kg/m2.
• Agree to use an adequate method of contraception (double barrier method) during the entire period of participation in the study and for 3 weeks after its completion.
• Consent to all restrictions imposed during the study.
• Citizenship of the Russian Federation.

Exclusion Criteria:

• Burdened allergic history, drug intolerance.
• Hypersensitivity to heparin, semaglutide and any of the excipients of the study drug.

• Any acute and chronic diseases, incl. but not limited to:

  1. diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract (including diseases of the colon), liver, kidneys, blood;
  2. positive test results for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum).
• Deviations from normal values of heart rate (60-80), SBP (100-130 mm Hg), DBP (60-85 mm Hg), NPV (16-20), body temperature (35.7 - 37.0 °C).
• ECG Deviations, according to a specialist, during screening.
• laboratory tests results deviations from the normal values.
• Hard-to-reach veins of the upper extremities, vein thrombosis, thrombophlebitis in a family history of close relatives, "compromised" veins due to frequent previous venipunctures.
• Surgical interventions on the gastrointestinal tract (with the exception of appendectomy) in history.
• Acute infectious diseases less than 4 weeks prior to screening.
• History of medullary thyroid cancer and/or multiple endocrine neoplasia type 2, including family history.
• History of chronic or acute pancreatitis.
• Regular use of any prescription and over-the-counter medications (in particular drugs that reduce heart rate), dietary supplements, vitamins less than 2 weeks before the start of screening, taking St. John's wort (Hypericum perforatum) less than 30 days before the start screening.
• Use of semaglutide or other analogues of human glucagon-like peptide-1 (GLP-1) within 6 months before screening.
• Use of depot injections or implants of any medications 3 months before the start of screening.
• Significant blood loss (more than 450 ml of blood or plasma) within 3 months prior to screening, due to, including, but not limited to, blood donation, blood loss during advanced surgery or trauma.
• Drinking alcohol in quantities exceeding 10 units per week (on average) (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of dry wine or 50 ml of strong alcoholic drinks) or anamnestic information about alcoholism, drug addiction, abuse of strong drugs.
• Positive test results for alcohol, drug use and the use of strong drugs.
• Nicotine addiction (regular tobacco use, including smoking of all types of electronic cigarettes, hookahs, snuff, etc. less than 6 months prior to screening).
• Participation in a clinical trial of any drugs (including experimental drugs) or experimental medical devices for 3 months or 5 half-lives prior to Screening, whichever is longer.
• Any diet (eg vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity such as heavy lifting) that may interfere with the study.
• Taking drugs that have a pronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, etc.) less than 30 days before screening.
• Consumption of citrus fruits (including grapefruit and grapefruit juice), cranberries (juice, fruit drink, etc.), starfruit or pomelo 14 days before the start of screening.
• Incomplete recovery from surgery or surgery scheduled while the volunteer was participating in the study.
• Other diseases/conditions that, in the opinion of the researcher, may affect the pharmacokinetics of the active substance of the drugs or increase the risk to the health of the volunteer.
• Tattoos or piercings less than 30 days before screening.
• Volunteers who are obviously or likely, in the opinion of the investigator, unable to understand and evaluate the information on this study as part of the informed consent process, in particular regarding expected risks and possible discomfort.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GP40221; GP40221 is administered subcutaneously into the subcutaneous fat of the anterior abdominal wall at a dose of 0.5 mg using a pen injector.	Drug: GP40221; Solution for Subcutaneous Administration 1.34 mg/ml; Other Names: semaglutide
Active Comparator: ozempic; Ozempic® is administered subcutaneously into the subcutaneous fat of the anterior abdominal wall at a dose of 0.5 mg using a pen injector	Drug: ozempic; Solution for Subcutaneous Administration 1.34 mg/ml; Other Names: semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 0-t	Total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to the collection of the last blood sample with a determined concentration of the active substance at time point t	-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
Cmax	Maximum concentration of the active substance in the blood plasma of volunteers during the observation period	-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tmax	Time to reach the maximum concentration (Cmax) of an active substance in the blood plasma of volunteers	-60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
t1/2	half-life of an active substance	-60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
λz	constant of elimination of an active substance	-60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection
AUC0-∞	total area under the "concentration of an active substance - time" curve in the time interval from 0 (the moment of drug administration) to infinity	-60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection

Collaborators and Investigators

• Sponsor: Geropharm
• Investigators: Principal Investigator: Sergei Noskov, MD, Pr., Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3"

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): May 5, 2024
• Study Completion (Actual): May 5, 2024

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: semaglutide; ozempic
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: GP40221-P4-01-01

Drug and device information, study documents

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