Tolerability and Pharmacokinetics
Conditions
Interventions
Single dose of tolerability:Subcutaneous administration of a single dose of rhEPO-Fc
Multiple dose of tolerability:Subcutaneous administration of rhEPO-Fc once weekly for 7 consecutive weeks
Single dose of pharmacokinetics:Subcutaneous administration of a single dose of rhEPO-Fc
single and multiple dose of pharmacokinetics:Subcutaneous administration of rhEPO-Fc once weekly for 8 weeks
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: All subjects enrolled in this clinical trial must be healthy nonsmokers, 18 to 40 years of age, with a body mass index (BMI) of 19 to 24 kg/m2. The ratio of male and female volunteers was 1:1. Physical and mental health will be determined by medical interview, complete physical examination, chest X-ray, 12-lead ECG, vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and clinical standard laboratory tests, including hematology (red blood cell count, white blood cell with differential cell count, platelet count, hemoglobin, and hematocrit), blood chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, alkaline phosphatase, albumin, and total protein glucose), and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, nitrites, blood, and leucocytes). Subjects must to test negative for hepatitis C virus, hepatitis B-surface antigen, and HIV. Female volunteers must be required to have a negative pregnancy test at the time of screening.Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: Volunteers were excluded if they have any clinically significant abnormality, have a history of an allergy or hypersensitivity to any chemicals, have donated blood or participated in another investigational drug study within 12 weeks before entry into this study, or have received any drug treatment within 2 weeks before the study. Volunteers with any history or evidence of a hepatic, renal, gastrointestinal, endocrine, pulmonary, hematological, cardiovascular, vascular, or collagen disease will also be excluded from this study. A history of muscle disease, nervous system disease, or a psychiatric disorder that might hinder compliance with the study protocol, as well as a history of alcohol, tobacco, or drug abuse, are also exclusion criteria. Female subjects who are pregnant or breastfeeding are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability;pharmacokinetics; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Outcome results
None listed