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

• Status: Recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
• Treatments: Panitumumab

Criteria

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.