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
Overview
- Phase
- Phase 1
- Intervention
- CT-P16
- Conditions
- Healthy
- Sponsor
- Celltrion
- Enrollment
- 141
- Locations
- 3
- Primary Endpoint
- AUC0-inf
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
CT-P16
CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Intervention: CT-P16
EU-approved Avastin
EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Intervention: EU-approved Avastin
US-licensed Avastin
US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Intervention: US-licensed Avastin
Outcomes
Primary Outcomes
AUC0-inf
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)