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.

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.)