Healthy
Conditions
Brief summary
A first-time in human study to investigate the safety, tolerability and pharmacokinetics of RD01 in healthy Chinese subjects
Detailed 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.
Interventions
DRUGRD01
single S.C. dose of RD01 for subjects in test group
DRUGPlacebo
single S.C. dose of placebo for subjects in placebo group
Sponsors
Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of Adverse Events | up to 35 days | incidence of adverse events using the NCI Common Terminology Criteria for Adverse Events version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum concentration （Cmax） | for 35days | Plasma RD01 concentration will be quantified for each arm to determine Cmax, defined as the maximum observed concentration of RD01 in plasma. |
| time to reach Cmax （Tmax） | for 35days | 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 |
| terminal elimination half life（t½） | for 35days | It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase. |
| the changes of reticulocyte (10^9/L) after treatment | for 35days | The reticulocyte of participants the was measured before and after the treatment |
| the changes ofHematocrit（%） after treatment | for 35days | The Hematocrit of participants the was measured before and after the treatment |
| the changes of erythrocyte（10^12/L） after treatment | for 35days | The erythrocyte of participants the was measured before and after the treatment |
| the changes of hemoglobin (g/L) after treatment | for 35days | The hemoglobin of participants the was measured before and after the treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anti-drug antibody endpoint | up to 35 days | Blood level for anti-EPO and anti-RD01 antibody |
Countries
China
Outcome results
None listed