Healthy
Conditions
Keywords
PK & PD study, rhEPO, Pegylated rhEPO, male healthy subject
Brief summary
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.
Interventions
DRUGPegylated rhEPO
DRUGEPIAO®
Sponsors
Xiamen Amoytop Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Agree to all the purposes of the study by signing and dating the informed consent. * Male, aged between 18 and 40 years, age disparity of each group should less than 10 years. * Body weight ≥ 50kg, and body mass index (BMI) between 18 kg/m2 and 26kg/m2 at screening. * Hemoglobin between 131g/L and 162g/L, hematocrit between 41% and 49%, and reticulocyte between 0.5% and 2%. * Transferrin saturation and serum ferritin are in the normal range. * Physical condition: vital signs, physical examination and laboratory tests ( including routine blood, biochemical tests, coagulation indicators, serum folic acid, vitamin B12, urine test, HBsAg, anti-HCV, anti-HIV, Immunoglobulin (IgA, IgM, IgG), thyroid function (T3, T4, TSH), autoantibodies), chest-X-ray, 12-lead ECG should all in normal range, or without significant clinically abnormal.
Exclusion criteria
* Presence of organic disease in heart, liver, kidney, brain; or presence of cardiovascular, pulmonary, gastrointestinal, urinary, neurological, endocrine, immunity, genitourinary or other systems disease. * Subjects with familial genetic disease, mental illness, or physical disability. * History of drug allergy. * Orthostatic hypotension, systolic blood pressure \<90mmHg. * Habitual medication, including Chinese herbal medicine. * Poor inclusion conditions (e.g. infirm). * Smoker (smoke everyday or more than 7 cigarettes per week)，alcoholics (more than 40g/day, equivalent to 100ml/day of 50 degree of white spirit). * Participate in any other drug trials as the subjects within the previous 3 months. * As blood donated within the previous 3 months, or experienced massive blood loss due to trauma or surgery. * Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g. poor compliance).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of rhEPO | 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration | * Time frame of day 12 for comparator drug: 0 hour before drug administration and 1, 3, 6, 9, 14, 16 hour after last dose administration. * For comparator drug, blood collection of 0, 48, 96, 168, 216, and 264 hour should before drug administration. |
| Plasma reticulocyte count | 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration. | For comparator drug, blood collection of 48, 96, 168, 216, and 264 hour should before drug administration |
| Plasma hemoglobin concentration | 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration. | For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration |
| Plasma hematocrit | 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration. | For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration |
Countries
China
Outcome results
None listed