Comparing the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Males.

Study Overview
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Brief Summary
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A randomized, double-blind and parallel group study to compare the pharmacokinetic and safety of QL1203 and Vectibix® in healthy males.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind and Single-dose Study to Compare the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Male Subjects.

Conditions
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Healthy Males

Intervention / Treatment
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* Drug: QL1203
* Drug: Vectibix®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL1203<br>Participants only receive QL1203, 6mg/kg on Day 1. | Drug: QL1203<br>* 6 mg/kg intravenous (IV) infusion only once，on the first day.<br>|
| Active Comparator: Vectibix®<br>Participants only received Vectibix®，6 mg/kg on Day 1. | Drug: Vectibix®<br>* 6 mg/kg intravenous (IV) infusion only once，on the first day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC0-t ) | Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t. | 36 days |