Title
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RD01 (Pegerythropoietin) in Healthy Chinese Volunteers
A Phase 1, Randomised, Double-blind, Single-centre, Placebo-controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single S.C. Doses of RD01 (Pegerythropoietin) in Healthy Chinese Subjects
A first-time in human study to investigate the safety, tolerability and pharmacokinetics of RD01 in healthy Chinese subjects
A Phase 1, Randomised, Double-blind, Single-centre, Placebo-controlled, Dose-Escalation study to evaluate the Safety, Tolerability and Pharmacokinetics of single S.C. doses of RD01 (Pegerythropoietin) in Healthy Chinese Subjects. Doses were escalated from 0.2μg/kg up to 4.8μg/kg with 12 subjects (randomized to 5:1 for test or placebo) in every cohort.
single S.C. dose of RD01 for subjects in test group
single S.C. dose of placebo for subjects in placebo group
Inclusion Criteria: Age 18~60, both male and female Healthy adults without obvious organic diseases and nervous/mental diseases BMI 19~26 kg/m2, inclusive Subject is willing and able to provide written informed consent, and would complete the whole study procedures Serum ferritin level is within the reference range at screening within 4 weeks before enrollment Should be fully recovered, when has received surgical treatment Exclusion Criteria: Has allergy history or past drug allergy history, or allergy history to polyethylene glycol Has taken any drug within 5 half-time or 4 weeks before enrollment Has taken any drug known to harm organ within 12 weeks before enrollment Participated in other clinical trials within 12 weeks before enrollment Donated blood or received blood transfusion, or received therapy of recombinant erythrocytogenetic stimulating protein or rHuEPO within 12 weeks before enrollment Female subject receives therapy of hormone after menopause Subject with clinically significant abnormal of lab tests determined by the investigator (subjects with Hb or Rtc level outrange the up-limit of reference were suggested to be excluded) Subject with HBsAg, HBeAg, HCV-Ab, HIV-Ab or Treponema pallidum antibody positive Clinically diagnosed as vitamin B12 or folic acid deficiency Previous history of coronary heart disease or congestive heart failure, or ECG shows clinical significance of abnormalities With history of malignant tumors or suspicious Subject with active infection History of autoimmune disease, or being treated with immunosuppressive agents With severe, progressive or uncontrolled diseases of liver, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerves or brain Pregnant or lactating women, or subject planning to has descendants during trial or within 12 weeks after dosing Drug abusers, drug addicts, or smokers (5 or more cigarettes per day), alcoholics (14 or more units per week, 1 unit = 360 mL of beer or 150 mL of wine or 45 mL of alcohol 40% or more) Other factors that might influence the attendance determined by investigators, including poor compliance (long-term travel, planned relocation, mental illness, lack of motivation, etc.)
