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

NCT06232902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

  • Tumor

Interventions

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2024-11-18
Completion
2024-11-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06232902 on ClinicalTrials.gov