Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

Last updated: December 14, 2022
Sponsor: Geropharm
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05652595
GP40141-P4-31
  • Ages 18-45
  • Male
  • Accepts Healthy Volunteers

Study Summary

Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.

Eligibility Criteria

Inclusion

Inclusion Criteria: Signed informed consent form. Male aged 18 to 45 years. Verified diagnosis is "healthy"according to data Standard clinical, laboratory and Instrumental methods of examination. The level of platelets count (according to the clinical blood test) at screening rangedfrom the lower threshold of reference values to 306×109/l (inclusive). Body mass index between 18,5 and 30 kg/m2, with body weight 60-100 kg Consent to complywith an adequate method of effective contraception throughout the study. The consent of volunteers to all restrictions imposed during the study. Russian FederationCitizens

Exclusion

Exclusion Criteria: History of allergic problems/events. Hypersensitivity to heparin, romiplostim or any of theexcipients of the drugs studied or E.coli protein. Any acute and chronic diseases, including but not limited to cardiovascular systemdiseases, bronchopulmonary diseases, neuroendocrine systems diseases, as well as diseasesof the gastrointestinal tract, liver, kidneys, blood. Positive testing for hepatitis C (antibodies) or hepatitis B (surface antigen), HIV (antibodies to HIV-1/2), syphilis (antibodies to Treponema pallidum). The WHO norms deviations of the heart rate (60-89), Sistolic BP (90-139 mm Hg), Diatolic BP (60-89 mm Hg), respiratory rate (12-20), body temperature (35.7 - 37.0 °C). Abnormal ECG during screening. Abnormal results of laboratory methods research.Inaccessible veins of the upper extremities, vein thrombosis, thrombophlebitis in theanamnesis or in the family history of the next of kin, "compromised" veins due to frequentprevious venipuncture. Surgical interventions on the spleen, splenectomy in anamnesis. Acute infectious diseasesin less than 4 weeks before the start of the study. Diseases of the blood, hematopoieticorgans and disorders, involving the immune mechanism (ICD-10: D50-D89) in history. History of arterial and venous thromboses. Presence of malignant (ICD-10: C00-C97) orunknown malignancy of neoplasms (ICD-10: D37-D48), as well as neoplasms in situ (ICD-10:D00-D09) within the last 5 years. Regular intake of medications, including vitamins, herbal preparations, and dietarysupplements, less than 2 weeks before the start of the study. Incomplete recovery from surgery or surgery scheduled for the duration of the subject'sparticipation in the study. Significant loss of blood within 3 months prior to screening, including but not limited toblood donation or extended surgery or trauma resulting in the blood loss. History of alcohol or drugs abuse or any indication of the regular use of more than 10units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%). Positive test results for alcohol or drug use. Nicotine addiction, regular use of tobacco,including all types of electronic cigarettes, less than 6 months prior to screening. Participation in a clinical trial of any drugs (including experimental) or experimentalmedical devices for 3 months or 5 half-lives, whichever is longer, before the study. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before thestart of the study. Any diet (for example, vegetarian, fasting, etc.) or lifestyle (including night work andextreme physical activity) that may interfere with the study. Psychiatric disorders, history of epilepsy and seizures. Taking medications that have apronounced effect on hemodynamics, liver function, etc. (barbiturates, omeprazole,cimetidine, etc.) less than 30 days before the start of the study. Volunteers who are obvious or likely, according to the investigator, are unable tounderstand and evaluate the information on this study as part of the process of signinginformed consent, in particular regarding the expected risks and possible discomfort.

Study Design

Total Participants: 56
Study Start date:
June 03, 2022
Estimated Completion Date:
September 30, 2024

Study Description

The goal of this study, conducted as a double-blind, randomized, cross-over study of comparative pharmacodynamics and pharmacokinetics, is to compare pharmacodynamics, pharmacokinetics, and safety of drugs containing romiplostim - GP40141 and Nplate® in healthy volunteers after a single subcutaneous injection.

research objectives is:

  1. Evaluate pharmacodynamic and pharmacokinetic parameters of active ingredients of preparations GP40141 and Enplate®.

  2. Conduct a comparative analysis of pharmacodynamic and pharmacokinetic parameters of active substances drugs GP40141 and Enplate®.

  3. Conduct a comparative analysis of data on adverse events (AE) and evaluate immunogenicity after a single subcutaneous administration of GP40141 versus Enplate®. A conclusion about the biosimilarity of drugs will be made by assessing 90% confidence intervals for the ratios of the geometric mean values of the primary pharmacodynamic parameters.

The safety of the compared drugs will be assessed by emergence and development of AE.

Connect with a study center

  • Yaroslavl Region "Clinical Hospital No. 3", ,, Mayakovskogo st., 61

    Yaroslavl, 150007
    Russian Federation

    Active - Recruiting

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