NCT04234594

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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".

Conditions

• Healthy Males

Interventions

Type	Name	Description
DRUG	QL1203	6 mg/kg intravenous (IV) infusion only once，on the first day.
DRUG	Vectibix®	6 mg/kg intravenous (IV) infusion only once，on the first day.

Timeline

• Start date: 2019-10-28
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-01-21
• Last updated: 2020-05-19

Locations

2 sites across 1 country: China