MedTrace Logo

To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin

NCT03247673 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2020-03-26

Study results available
· View outcomes & findings →

Summary

This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects

Conditions

  • Healthy

Interventions

DRUG

CT-P16

CT-P16 is a biosimilar product for Avastin

DRUG

EU-approved Avastin

EU-approved Avastin

DRUG

US-licensed Avastin

US-licensed Avastin

Sponsors & Collaborators

Principal Investigators

  • Sung Young Lee · Celltrion

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2017-12-22
Completion
2018-01-17

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

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 NCT03247673 on ClinicalTrials.gov