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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: RD01
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Doses were escalated from 0.2μg/kg up to 4.8μg/kg | Drug: RD01<br>* single S.C. dose of RD01 for subjects in test group<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single S.C. dose of placebo for subjects in placebo group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Adverse Events | incidence of adverse events using the NCI Common Terminology Criteria for Adverse Events version 4.0. | up to 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | for 35days | 
| the changes of hemoglobin (g/L) after treatment | The hemoglobin of participants the was measured before and after the treatment | for 35days | 
| the changes of reticulocyte (10^9/L) after treatment | The reticulocyte of participants the was measured before and after the treatment | for 35days | 
| the changes ofHematocrit（%） after treatment | The Hematocrit of participants the was measured before and after the treatment | for 35days | 
| the changes of erythrocyte（10^12/L） after treatment | The erythrocyte of participants the was measured before and after the treatment | for 35days |