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

NCT04234594 | Unknown Phase 1

• 1 other identifier: QL1203-002
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Males

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

QL1203

EXPERIMENTAL

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

Drug: QL1203

Vectibix®

ACTIVE COMPARATOR

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

Drug: Vectibix®

Interventions

QL1203 DRUG

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

QL1203

Vectibix® DRUG

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

Vectibix®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Guizhou Cancer Hospital

Guiyang, Guizhou, 550000, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

MeSH Terms

Interventions

Panitumumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Weiwei Ouyang, Professor

  Cancer Hospital of Guizhou Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunjiang Yu, CMO

CONTACT

0531-83129659; shunjiang.yu@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: October 28, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-01

Locations

CN (2)