Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02725606

Chemotherapy-induced Neutropenia

UNKNOWN PHASE1

Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

NCT03246009

Chemotherapy-induced Neutropenia Cancer, Breast

COMPLETED PHASE1

Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

NCT03251768

Chemotherapy-induced Neutropenia

COMPLETED PHASE2

Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

NCT02465801

Chemotherapy-induced Neutropenia

COMPLETED PHASE2

Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor

NCT07096479

Chemotherapy-induced Neutropenia

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy-induced Neutropenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type BIOLOGICAL

single SC injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GW003

single SC injection

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
* At least 50kg weight,BMI between 19 and 25kg/m2
* No tobacco, alcohol and other bad habits
* No history of drug allergy and biological agents allergy and other allergies
* Not used biological agents and other drugs within three months before participated in this test
* Not participated in other test or donated blood within three months before participated in this test
* The medical history、physical examination、laboratory examination is normal or slightly abnormal
* Subjects can obey the clinical trial protocol
* Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily.

Exclusion Criteria

* History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
* History of drug allergy and biological agents allergy and other allergies
* Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
* Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
* Subjects accepted major surgery 4 weeks before drug administration
* Subjects vaccinated live vaccine 3 months before drug administration
* Subjects with the history of drug abuse 5 years before drug administration
* As the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months
* Clinical and laboratory examination results is abnormal and have clinical significance
* Subjects with poor compliance or have any unfavorable factors to participate in this test
* Subjects can not complete the research
* The researchers and their family members.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes