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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CT-P16; Drug: US-licensed Avastin; Drug: EU-approved Avastin

• Registration Number: NCT03247673
• Lead Sponsor: Celltrion

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-03
• Study Start: 2017-08-07
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Primary Completion: 2017-12-22
• Study Completion: 2018-01-17
• Results First Submitted: 2019-04-08
• Results First Submitted QC: 2019-07-17
• Results First Posted: 2019-07-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P16	CT-P16	CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects
US-licensed Avastin	US-licensed Avastin	US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
EU-approved Avastin	EU-approved Avastin	EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects

Primary Outcome Measures

Name	Time	Method
AUC0-inf	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	Area under the concentration-time curve from time zero to infinity
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	Maximum Serum Concentration (Cmax)
AUC0-last	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	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration

Secondary Outcome Measures

Name	Time	Method
Additional Pharmacokinetics (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	To assess the additional PK of study drugs (Time to Cmax)
Number of Participants With Anti-Drug Antibody Positive	up to 15 weeks	number of participants with anti-drug antibody positive at post-dose

Trial Locations

Locations (3)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Seoul St.Mary's hospital; 🇰🇷 Seoul, Korea, Republic of