Clinical trial NCT02643901: Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
Official title: The Single-Dose Tolerability and PK/PD Study of Recombinant (Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy-induced Neutropenia
Lead sponsor: Jiangsu T-Mab Biopharma Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-12-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to day 21
Secondary outcomes:
measure: Frequency of subjects with Anti-GW003 antibody
timeFrame: up to 6 months after the trial
measure: half-life(consist of distribution and elimination half-life) for GW003
timeFrame: up to day 14
measure: area under the concentration-time curve(AUC) for GW003
timeFrame: up to day 14
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Hematonosis Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Hematonosis Hospital
name: Qi Junyuan, doctor
role: PRINCIPAL_INVESTIGATOR
References: