NCT03919448

A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

A Double-blind, Randomized, Balanced, Parallel Group, Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Laboratorios Richmond S.A.C.I.F. · Industry
• Sex: Male
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin® (reference product) and Cizumab® (Indian origin), to establish similarity.

Detailed description

Three-way bridge phase 1 trial. It is conducted in healthy, male adult subjects, it is single-dose, double-blind, parallel groups, randomized and balanced. Blood samples are collected for up to 90 days, to determine serum drug concentration and anti-drug antibodies. Safety and tolerability are also assessed.

Conditions

• Pharmacokinetics
• Safety Issues

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Single-dose infusion

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-09-11
• Completion: 2019-09-11
• First posted: 2019-04-18
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

1 site across 1 country: Argentina