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

• Status: Completed
• Trial end date: 2018-01-17
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Celltrion
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Healthy male subjects between the ages of 19 and 55 years, both inclusive

• Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg

Exclusion Criteria:

• Subject is a female.

• Clinically significant allergic reactions, hypersensitivity

• A disease classed as significant by the Investigator

• Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury

• Any malignancy

• Undergone treatment with an investigational drug or participated in another clinical trial

• Plans to father a child or donates sperms