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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy Males
• Intervention / Treatment: Drug: QL1203; Drug: Vectibix®

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 Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Recruiting
      • Guizhou Cancer Hospital
      • Contact: Weiwei Ouyang, Professor
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
      • Contact: Hui Wu, Professor
      • Contact: Li He, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Weiwei Ouyang, Professor, Cancer Hospital of Guizhou Province

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: QL1203-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No