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

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247673
• Other study ID #: CT-P16 1.1
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2017
• Est. completion date: January 17, 2018

Study information

• Verified date: March 2020
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 17, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CT-P16
CT-P16 is a biosimilar product for Avastin
• EU-approved Avastin
EU-approved Avastin
• US-licensed Avastin
US-licensed Avastin

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul St.Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf	Area under the concentration-time curve from time zero to infinity	pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Primary	Cmax	Maximum Serum Concentration (Cmax)	pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Primary	AUC0-last	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration	pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Secondary	Additional Pharmacokinetics (Time to Cmax)	To assess the additional PK of study drugs (Time to Cmax)	pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI
Secondary	Number of Participants With Anti-Drug Antibody Positive	number of participants with anti-drug antibody positive at post-dose	up to 15 weeks

External Links

•   Celltrion, Inc. homepage