A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RD01 (Pegerythropoietin) in Healthy Chinese Volunteers

Shengzhen Sciprogen Bio-pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: RD01

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03657238

3SBio-RD01-101a

Details and patient eligibility

About

A first-time in human study to investigate the safety, tolerability and pharmacokinetics of RD01 in healthy Chinese subjects

Full description

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.

Enrollment

84 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.)