Healthy Volunteers
Conditions
Brief summary
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
Interventions
DRUGrecombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
A single intravenous infusion of HS627 420mg
DRUGPerjeta ®
A single intravenous infusion of Perjeta ®420mg
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male aged 18-40. * The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg. * The subjects have no family planning within 3 months and could select contraceptive method * The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol. * Echocardiography showed left ventricular ejection fraction (LVEF) \> 50% ,which two weeks before administration of experimental drug.
Exclusion criteria
* The subjects with a history of malignant tumor. * The subjects who has received any live vaccine within 6 months prior to signing the informed consent. * The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening. * The subjects who had undergone surgery within 2 months prior to signing the informed consent. * Anti-drug antibody (ADA) detection positive. * Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC)0-∞ | 150 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ |
| Area under the plasma concentration versus time curve (AUC)0-t | 150 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t |
| Peak Plasma Concentration (Cmax) | 150 days | Evaluation of Peak Plasma Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total clearance(CL) | 150 days | Evaluation of the total clearance(CL) |
| elimination half-life time(T1/2) | 150 days | Evaluation of elimination half-life time(T1/2) |
Countries
China
Outcome results
None listed