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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Xuan Wu Hospital, Capital Medical University
Beijing, China
incidence of Adverse Events
incidence of adverse events using the NCI Common Terminology Criteria for Adverse Events version 4.0.
Time frame: up to 35 days
maximum concentration (Cmax)
Plasma RD01 concentration will be quantified for each arm to determine Cmax, defined as the maximum observed concentration of RD01 in plasma.
Time frame: for 35days
time to reach Cmax (Tmax)
Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them
Time frame: for 35days
terminal elimination half life(t½)
It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase.
Time frame: for 35days
the changes of hemoglobin (g/L) after treatment
The hemoglobin of participants the was measured before and after the treatment
Time frame: for 35days
the changes of reticulocyte (10^9/L) after treatment
The reticulocyte of participants the was measured before and after the treatment
Time frame: for 35days
the changes ofHematocrit(%) after treatment
The Hematocrit of participants the was measured before and after the treatment
Time frame: for 35days
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the changes of erythrocyte(10^12/L) after treatment
The erythrocyte of participants the was measured before and after the treatment
Time frame: for 35days