NCT03657238

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

August 24, 2018

Last Update Submit

March 13, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • maximum concentration （Cmax）

    for 35days

  • time to reach Cmax （Tmax）

    for 35days

  • terminal elimination half life（t½）

    for 35days

  • the changes of hemoglobin (g/L) after treatment

    for 35days

  • the changes of reticulocyte (10^9/L) after treatment

    for 35days

  • +2 more secondary outcomes

Other Outcomes (1)

  • Anti-drug antibody endpoint

    up to 35 days

Study Arms (2)

Experimental

EXPERIMENTAL

Doses were escalated from 0.2μg/kg up to 4.8μg/kg

Drug: RD01

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RD01DRUG

single S.C. dose of RD01 for subjects in test group

Experimental
PlaceboDRUG

single S.C. dose of placebo for subjects in placebo group

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

  • Hu C, Sun W, Wu Y, Huang J, Zhang X, Zhang L. A Phase I Dose-Escalation Study of The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Polyethylene Glycol-Erythropoietin (PEG-EPO) in Healthy Subjects. Clin Ther. 2024 Aug;46(8):636-643. doi: 10.1016/j.clinthera.2024.06.018. Epub 2024 Aug 8.

    PMID: 39117488DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2018

First Posted

September 5, 2018

Study Start

April 8, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations

CN(1)