Clinical trial NCT03657238: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RD01 (Pegerythropoietin) in Healthy Chinese Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: incidence of Adverse Events
timeFrame: up to 35 days
Secondary outcomes:
measure: maximum concentration （Cmax）
timeFrame: for 35days
measure: time to reach Cmax （Tmax）
timeFrame: for 35days
measure: terminal elimination half life（t½）
timeFrame: for 35days
measure: the changes of hemoglobin (g/L) after treatment
timeFrame: for 35days
measure: the changes of reticulocyte (10^9/L) after treatment
timeFrame: for 35days
measure: the changes ofHematocrit（%） after treatment
timeFrame: for 35days
measure: the changes of erythrocyte（10^12/L） after treatment
timeFrame: for 35days
Other outcomes:
measure: Anti-drug antibody endpoint
timeFrame: up to 35 days
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital, Capital Medical University
Study officials:
References: