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

Launched by GEROPHARM · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called GP40141, comparing it to another treatment known as Enplate®. The goal is to understand how these drugs work in the body and how they are processed after being injected. Researchers are particularly interested in how safe the drugs are and how well they perform in healthy volunteers.

To participate, you need to be a healthy male between the ages of 18 and 45, with a specific range for body weight and body mass index. Participants must be willing to follow the study rules and use effective contraception during the trial. If you're interested, know that the study is currently looking for volunteers, and those who qualify can expect to receive a single injection while being closely monitored for any effects or side effects. It's important to note that individuals with certain health issues, allergies, or those taking specific medications will not be eligible for this study.

Gender

MALE

Eligibility criteria

• 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 ranged from 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 comply with an adequate method of effective contraception throughout the study.
• • The consent of volunteers to all restrictions imposed during the study. Russian Federation Citizens
• Exclusion Criteria:
• • History of allergic problems/events. Hypersensitivity to heparin, romiplostim or any of the excipients of the drugs studied or E.coli protein.
• • Any acute and chronic diseases, including but not limited to cardiovascular system diseases, bronchopulmonary diseases, neuroendocrine systems diseases, as well as diseases of 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 the anamnesis or in the family history of the next of kin, "compromised" veins due to frequent previous venipuncture.
• • Surgical interventions on the spleen, splenectomy in anamnesis. Acute infectious diseases in less than 4 weeks before the start of the study. Diseases of the blood, hematopoietic organs 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) or unknown 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 dietary supplements, less than 2 weeks before the start of the study.
• • Incomplete recovery from surgery or surgery scheduled for the duration of the subject's participation in the study.
• • Significant loss of blood within 3 months prior to screening, including but not limited to blood 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 10 units 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 experimental medical 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 the start of the study.
• • Any diet (for example, vegetarian, fasting, etc.) or lifestyle (including night work and extreme physical activity) that may interfere with the study.
• • Psychiatric disorders, history of epilepsy and seizures. Taking medications that have a pronounced 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 to understand and evaluate the information on this study as part of the process of signing informed consent, in particular regarding the expected risks and possible discomfort.

Trial Officials