Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers

NCT05864261 | Completed Phase 4

• 1 other identifier: 2022-I-JT1801-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers

Conditions

Renal Anemia

Outcome Measures

Primary Outcomes (2)

• AUC0-t

  PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-t

  Pre-dose and after dose 20 days

• AUC0-∞

  PK parameters comparison between JT1801 and darbepoetin alfa: AUC0-∞

  Pre-dose and after dose 20 days

Secondary Outcomes (5)

• TEmax

  Pre-dose and after dose 15 days

• Emax

  Pre-dose and after dose 15 days

• AUEC0-t

  Pre-dose and after dose 15 days

• ΔAUEC0-t

  Pre-dose and after dose 15 days

• ΔEmax

  Pre-dose and after dose 15 days

Study Arms (2)

JT1801

EXPERIMENTAL

Drug: JT1801 60ug

NESP

ACTIVE COMPARATOR

Drug: NESP 60ug

Interventions

JT1801 60ug DRUG

JT1801, 60ug, IV injection

JT1801

NESP 60ug DRUG

NESP, 60ug, IV injection

NESP

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy adult male subjects.
• Age of 18 to 55 years, inclusive.
• Subject with BMI between 19 kg/m2 and 26 kg/m2 (inclusive); and a total body weight ≥50 kg.
• 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.
• Subject who provided written informed consent voluntarily after being fully informed of the study.
• Subject who is able to communicate well with the investigator and participate in the whole study process according to protocol.

You may not qualify if:

• During the screening period, vital signs measurement, physical examination, laboratory examination (blood routine, reticulocyte, urine routine, blood biochemistry, coagulation function, anemia, transferrin saturation, IgE detection), B-ultrasound examination, chest X-ray and 12-lead electrocardiogram examination showed abnormal results and were judged by the investigator to be clinically significant.
• 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.
• 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.
• Subjects with past or present history of hypertension, stroke, thromboembolism, convulsion, epilepsy or pure red cell aplasia.
• Subject with severe psychological or mental illness.
• Subject with a previous history of tumors.
• The investigator considers that there are other medical conditions that may affect the study results and the safety of the subjects.
• 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.
• Subject who have received other biologics within 6 months.
• 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.
• Positive for any of the virological tests, including human immunodeficiency virus, hepatitis C antibody, hepatitis B surface antigen, and treponema pallidum antibody.
• 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.
• 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.
• In the past year, the average daily consumption of excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ≈250mL).
• Those who smoked \> 5 cigarettes per day within 3 months before screening or could not refrain from smoking during the test.

Sponsors & Collaborators

• Yi Fang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 101149, China

Location

MeSH Terms

Interventions

Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pharmacy

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: May 15, 2023
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)