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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2020-09-30

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.

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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".

Conditions

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Healthy Males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QL1203

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

Group Type EXPERIMENTAL

QL1203

Intervention Type DRUG

6 mg/kg intravenous (IV) infusion only once，on the first day.

Vectibix®

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

Group Type ACTIVE_COMPARATOR

Vectibix®

Intervention Type DRUG

6 mg/kg intravenous (IV) infusion only once，on the first day.

Interventions

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QL1203

6 mg/kg intravenous (IV) infusion only once，on the first day.

Intervention Type DRUG

Vectibix®

6 mg/kg intravenous (IV) infusion only once，on the first day.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes