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

NCT06497049 | Completed Phase 1 DMC

• 1 other identifier: GP40221-P4-01-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics; Safety Issues; Bioequivalence

Keywords

semaglutide; ozempic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• tmax

  -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

  -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

  -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-∞

  -60, -30, 0 minutes) and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection

Study Arms (2)

GP40221

EXPERIMENTAL

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

ozempic

ACTIVE COMPARATOR

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

Interventions

GP40221 DRUG

Solution for Subcutaneous Administration 1.34 mg/ml

Also known as: semaglutide

GP40221

ozempic DRUG

Solution for Subcutaneous Administration 1.34 mg/ml

Also known as: semaglutide

ozempic

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: naturaly male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract (including diseases of the colon), liver, kidneys, blood;
• 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.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

Yarosslavl Clinical Hospital #3

Yaroslavl, Russia

Location

MeSH Terms

Interventions

semaglutide

Study Officials

• Sergei Noskov, MD, Pr.

  Yaroslavl State Institution of Healthcare "Clinical Hospital No. 3"

  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

Model Details: An open randomized study of comparative pharmacokinetics and biosimilarity of GP40221, solution for subcutaneous administration, 1.34 mg/ml and Ozempic®, solution for subcutaneous administration, 1.34 mg/ml in parallel groups in healthy volunteers

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: June 30, 2023
• Primary Completion: May 5, 2024
• Study Completion: May 5, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-05

Locations

RU (1)