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Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

NCT03246009 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.

To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration

Conditions

  • Chemotherapy-induced Neutropenia
  • Cancer, Breast

Interventions

DRUG

rHSA/GCSF

single injection-1.8mg

DRUG

rHSA/GCSF

single injection-2.1mg

DRUG

rHSA/GCSF

single injection-2.4mg

DRUG

rHSA/GCSF

multiple injection-1.8mg

DRUG

rHSA/GCSF

multiple injection-2.1mg

DRUG

rHSA/GCSF

multiple injection-2.4mg

Sponsors & Collaborators

  • Tianjin SinoBiotech Ltd.

    lead INDUSTRY

Principal Investigators

  • Binghe XU, MD · chinese academy of medical sciences tumor hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-21
Primary Completion
2017-04-10
Completion
2017-04-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246009 on ClinicalTrials.gov