Status:
COMPLETED
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Lead Sponsor:
Celltrion
Conditions:
Healthy
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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-appro...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2018
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT03247673
Start Date
August 7 2017
End Date
January 17 2018
Last Update
March 26 2020
Active Locations (3)
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1
Inje University Busan Paik Hospital
Busan, South Korea
2
Inha University Hospital
Incheon, South Korea
3
Seoul St.Mary's hospital
Seoul, South Korea