Phase 1
Completed N=141
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Healthy
Source: ClinicalTrials.gov NCT03247673 ↗
Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: AUC0-inf — 42034.90; 40413.44; 43017.95 h*ug/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-inf |
42034.90; 40413.44; 43017.95 | — |
| PRIMARY Cmax |
117.22; 114.06; 113.09 | — |
| PRIMARY AUC0-last |
41142.81; 39411.98; 41804.05 | — |
| SECONDARY Additional Pharmacokinetics (Time to Cmax) |
2.5; 2.5; 2.5 | — |
| SECONDARY Number of Participants With Anti-Drug Antibody Positive |
2; 2; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT03247673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.