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

Phase 1

• Conditions: Healthy Males
• Interventions: Drug: QL1203; Drug: Vectibix®

• Registration Number: NCT04234594
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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".

Study Timeline

• Study Start: 2019-10-28
• Status Verified: 2020-01
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-19
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 94

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL1203	QL1203	Participants only receive QL1203, 6mg/kg on Day 1.
Vectibix®	Vectibix®	Participants only received Vectibix®，6 mg/kg on Day 1.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Guizhou Cancer Hospital; 🇨🇳 Guiyang, Guizhou, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China