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

NCT02643901 | Completed Phase 1

• 1 other identifier: Tmab-GW003-NP-03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Neutropenia

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.

  up to day 21

Secondary Outcomes (3)

• Frequency of subjects with Anti-GW003 antibody

  up to 6 months after the trial

• half-life(consist of distribution and elimination half-life) for GW003

  up to day 14

• area under the concentration-time curve(AUC) for GW003

  up to day 14

Study Arms (5)

Ic-GW003 150ug/kg 4-8subjects

EXPERIMENTAL

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological: GW003

Ic-GW003 300ug/kg 6-8subjects

EXPERIMENTAL

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological: GW003

Ic-GW003 500ug/kg 6-8subjects

EXPERIMENTAL

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological: GW003

Ic-GW003 650ug/kg 6-8subjects

EXPERIMENTAL

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological: GW003

Ic-GW003 850ug/kg 6-8subjects

EXPERIMENTAL

Biological/Vaccine:GW003 freeze-dried powder single SC injection

Biological: GW003

Interventions

GW003 BIOLOGICAL

single SC injection

Ic-GW003 150ug/kg 4-8subjects; Ic-GW003 300ug/kg 6-8subjects; Ic-GW003 500ug/kg 6-8subjects; Ic-GW003 650ug/kg 6-8subjects; Ic-GW003 850ug/kg 6-8subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu T-Mab Biopharma Co.,Ltd: lead

Study Sites (1)

Tianjin Hematonosis Hospital

Tianjin, Tianjin Municipality, 30020, China

Location

Study Officials

• Qi Junyuan, doctor

  Tianjin Hematonosis Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 31, 2015
• Study Start: September 1, 2015
• Primary Completion: October 10, 2016
• Study Completion: October 10, 2016
• Last Updated: August 18, 2017

Record last verified: 2016-09

Locations

CN (1)