NCT06232902

A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers

A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers. Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 groups.

Detailed description

This is a phase I,single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers. Subjects would receive a single 100mg（4ml） of QL1101or EU-Avastin® injection.

Conditions

• Tumor

Interventions

Type	Name	Description
DRUG	QL1101	3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day
DRUG	Avastin®	3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day

Timeline

• Start date: 2024-06-20
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2024-01-31
• Last updated: 2024-12-18

Locations

1 site across 1 country: China