To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
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
1 other identifier
interventional
141
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2017
Typical duration for phase_1 healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2017
CompletedStudy Start
First participant enrolled
August 7, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2018
CompletedResults Posted
Study results publicly available
July 25, 2019
CompletedMarch 26, 2020
March 1, 2020
5 months
August 3, 2017
April 8, 2019
March 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (2)
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
Number of Participants With Anti-Drug Antibody Positive
up to 15 weeks
Study Arms (3)
CT-P16
EXPERIMENTALCT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects
EU-approved Avastin
ACTIVE COMPARATOREU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
US-licensed Avastin
ACTIVE COMPARATORUS-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celltrionlead
Study Sites (3)
Inje University Busan Paik Hospital
Busan, South Korea
Inha University Hospital
Incheon, South Korea
Seoul St.Mary's hospital
Seoul, South Korea
Related Publications (1)
Cho SH, Han S, Ghim JL, Nam MS, Yu S, Park T, Kim S, Bae J, Shin JG. A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males. BioDrugs. 2019 Apr;33(2):173-181. doi: 10.1007/s40259-019-00340-x.
PMID: 30850957DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Subject with unreliable PK parameter results were excluded from summary. Only treatment-emergent adverse events were summarized.
Results Point of Contact
- Title
- Clinical Planning Department Leader
- Organization
- Celltrion
Study Officials
- STUDY DIRECTOR
Sung Young Lee
Celltrion
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 14, 2017
Study Start
August 7, 2017
Primary Completion
December 22, 2017
Study Completion
January 17, 2018
Last Updated
March 26, 2020
Results First Posted
July 25, 2019
Record last verified: 2020-03