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Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer

NCT02725606 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-18

No results posted yet for this study

Summary

The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

BIOLOGICAL

Pegylated Recombinant Human G-CSF

subcutaneous

BIOLOGICAL

GW003

subcutaneous

Sponsors & Collaborators

  • Jiangsu T-Mab Biopharma Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Xichun Hu · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-09-30
Completion
2017-09-30

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 NCT02725606 on ClinicalTrials.gov