Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers
NCT ID: NCT05864261
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
74 participants
INTERVENTIONAL
2023-05-15
2023-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
JT1801
JT1801 60ug
JT1801, 60ug, IV injection
NESP
NESP 60ug
NESP, 60ug, IV injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JT1801 60ug
JT1801, 60ug, IV injection
NESP 60ug
NESP, 60ug, IV injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age of 18 to 55 years, inclusive.
3. Subject with BMI between 19 kg/m2 and 26 kg/m2 (inclusive); and a total body weight ≥50 kg.
4. Subject who agree to practive effective barrier contraception and avoid sperm donation during the entire study period and through at least 3 months after the last dose of study drug.
5. Subject who provided written informed consent voluntarily after being fully informed of the study.
6. Subject who is able to communicate well with the investigator and participate in the whole study process according to protocol.
Exclusion Criteria
2. History of chronic disease or serious disease in cardiovascular, liver, kidney, biliary tract, respiratory, blood, lymphatic, endocrinological, immunologic, psychiatric, neuromuscular, gastrointestinal system within three years.
3. Have a history of specific allergies (e.g. hives) or are allergic (e.g. are known to be allergic to two or more drugs), or have a history of allergy to this ingredient or to EPO drugs.
4. Subjects with past or present history of hypertension, stroke, thromboembolism, convulsion, epilepsy or pure red cell aplasia.
5. Subject with severe psychological or mental illness.
6. Subject with a previous history of tumors.
7. The investigator considers that there are other medical conditions that may affect the study results and the safety of the subjects.
8. Subject who had surgery within 6 months prior to screening period that the investigators determined would affect drug absorption, distribution, metabolism, or excretion, or who planned to have surgery during the study period.
9. Subject who have received other biologics within 6 months.
10. Those with a history of drug abuse (including the use of various narcotic drugs and psychotropic substances for non-medical destinations) or positive drug abuse screening (including morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, etc.) before the test.
11. Positive for any of the virological tests, including human immunodeficiency virus, hepatitis C antibody, hepatitis B surface antigen, and treponema pallidum antibody.
12. Subjects who have donated blood or lost blood from other reasons within 6 months prior to screening with a total of 400mL or received blood transfusions or used blood products.
13. Has a history of alcohol abuse within 1 year prior to screening, whereby drink more than 2 units of alcohol per week on average (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or alcohol breath test results greater than 0.0mg/100 ml.
14. In the past year, the average daily consumption of excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ≈250mL).
15. Those who smoked \> 5 cigarettes per day within 3 months before screening or could not refrain from smoking during the test.
16. Those who have used any drugs (prescription drugs, over-the-counter drugs, vitamins, Chinese herbal medicines, health supplements) within 30 days before enrollment.
17. Those who have used systemic glucocorticoids within 3 months before enrollment.
18. Those who have participated in other clinical trials within 3 months before enrollment.
19. Those who cannot tolerate venipuncture or have a history of needle sickness and blood sickness.
20. Those who have special requirements for diet and cannot accept a unified diet.
21. Subjects who received the vaccine within 3 months prior to the first dosing, or plan to be vaccinated during the study or within 1 week after the last dosing.
22. Those with a low probability of enrollment or poor adherence (such as frailty, physical exhaustion, dehydration or malnutrition, etc.) according to the judgment of the investigator.
18 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yi Fang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yi Fang
Professor of Pharmacy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-I-JT1801-01
Identifier Type: -
Identifier Source: org_study_id