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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: US-licensed Avastin; Drug: CT-P16; Drug: EU-approved Avastin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03247673

CT-P16 1.1

Details and patient eligibility

About

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

Full 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.

Enrollment: 141 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

141 participants in 3 patient groups

CT-P16

Experimental group

Description:

CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects

Treatment:

Drug: CT-P16

EU-approved Avastin

Active Comparator group

Description:

EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects

Treatment:

Drug: EU-approved Avastin

US-licensed Avastin

Active Comparator group

Description:

US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects

Treatment:

Drug: US-licensed Avastin