Healthy Males
Conditions
Brief summary
A randomized, double-blind and parallel group study to compare the pharmacokinetic and safety of QL1203 and Vectibix® in healthy males.
Detailed description
This is a phase I,single center, randomized, double-blind，single-dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of of QL1203 or Vectibix® in healthy male volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of QL1203 or Vectibix® in healthy male volunteers.
Interventions
DRUGQL1203
6 mg/kg intravenous (IV) infusion only once，on the first day.
DRUGVectibix®
6 mg/kg intravenous (IV) infusion only once，on the first day.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects sign the informed consent form and fully understand purpose, nature, process and possible adverse reactions of the study, and are able to complete the study according to the study plan requirements. * Male,18 years to 65 years of age. * Weight ≧50.0 kg; body mass index (BMI) in the range of 19.0～ 26.0 kg / m\^2. * Subjects have no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, psychiatric, nervous, gastrointestinal system diseases and the general health is good. * Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.
Exclusion criteria
* Subjects have used any biological product within 3 months prior to receiving the study drug, or have used any monoclonal antibody drugs within 9 months. * Subjects have anallergic history to study drug or any drug component; or persons with allergic history to two or more drugs and food. * Subjects have a history of interstitial lung disease. * Subjects have a history of keratitis or long-term wearing of contact lens. * Subjects have used any prescription drugs, over-the-counter medicines, Chinese herbal medicines, and vitamins within 2 weeks before receiving the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t ) | 36 days | Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t. |
Countries
China
Contacts
Primary ContactShunjiang Yu, CMO
Outcome results
None listed