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

Healthy Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234594
• Other study ID #: QL1203-002
• Status: Recruiting
• Phase: Phase 1
• Start date: October 28, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2020
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Shunjiang Yu, CMO
• Phone: 0531-83129659
• Email: shunjiang.yu[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Males

Intervention

Drug:
• QL1203
6 mg/kg intravenous (IV) infusion only once,on the first day.
• Vectibix®
6 mg/kg intravenous (IV) infusion only once,on the first day.

Locations

Country	Name	City	State
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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