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

Qilu Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Males

Treatments: Drug: QL1203; Drug: Vectibix®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04234594

QL1203-002

Details and patient eligibility

About

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

Full 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".

Enrollment: 94 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

QL1203

Experimental group

Description:

Participants only receive QL1203, 6mg/kg on Day 1.

Treatment:

Drug: QL1203

Vectibix®

Active Comparator group

Description:

Participants only received Vectibix®，6 mg/kg on Day 1.

Treatment:

Drug: Vectibix®