Primary Objective:To demonstrate pharmacokinetic biosimilarity of ONS-1045 (Oncobiologics) to the EU- and US licensed product of Avastin® following a single 2.0 mg/kg i.v. infusion, in healthy male adult subjects.Secondary objective:• To evaluate…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the following pharmacokinetic parameter:
• AUC0-* and ratio of the geometric least square means of test to reference
products and its associated 90% confidence interval
Secondary outcome
Secondary pharmacokinetic endpoints include:
• Other pharmacokinetic parameters derived from serum samples including AUC0-t,
Cmax, Tmax, kel, t1/2el, clearance (CL), and Vd
Safety endpoints include:
• Adverse events (AE).
• Clinical laboratory and vital signs.
• Immunogenicity assessments.
Background summary
ONS-1045 is being developed as a biosimilar to Avastin® (bevacizumab) which is
a recombinant human IgG1 monoclonal antibody specific for vascular endothelial
growth factor (VEGF).
Study objective
Primary Objective:
To demonstrate pharmacokinetic biosimilarity of ONS-1045 (Oncobiologics) to the
EU- and US licensed product of Avastin® following a single 2.0 mg/kg i.v.
infusion, in healthy male adult subjects.
Secondary objective:
• To evaluate the safety, tolerability, and immunogenicity of ONS-1045
(Oncobiologics) and the EU- and US-licensed product of Avastin®
following a single 2.0 mg/kg i.v. infusion in healthy male adult subjects.
• To evaluate pharmacokinetic biosimilarity of the EU- to the US-licensed
product of Avastin® following a single 2.0 mg/kg intravenous
(i.v.) infusion, in healthy male adult subjects.
Study design
single centre, double-blind, randomized, single-dose, 3-arm parallel study
Intervention
A single dose of 2 mg/kg ONS-1045, EU-licensed Avastin® or US-licensed Avastin®
will be administered
Study burden and risks
The active substance of ONS-1045 is essentially the same biological substance
as the marketed formulations of bevacizumab. Although there may be minor
differences between ONS-1045 and bevacizumab, the experience with bevacizumab
(Avastin) suggests that drugs of this class can be administered safely to
healthy volunteers.
Avastin® EU and Avastin® US are widely used drugs and the most frequent
reported side effects are gastrointestinal complaints (such as stomach ache,
nausea and diarrhoea). Besides, blood pressure elevations and proteinuria have
been described. As only a single (and lower) dose of bevacuzimab will be
administered to the subjects in this study, the side effects are not expected
to happen. However, the subjects will be monitored closely during the conduct
of the study to minimize risks
Clarke Drive 7 -
Cranbury, New Jersey 08512
US
Clarke Drive 7 -
Cranbury, New Jersey 08512
US
Listed location countries
Age
Inclusion criteria
- Healthy Male subjects
- Age >=18 and <=55 years;
- Moderate to not smoking
- Body mass index 18.5- 30 kg/m2;
- Able and willing to give informed consent
Exclusion criteria
- Clinical significant laboratory abnormalities
- Signs and symptoms of congestive Heart Failure;
- Presence of non-healing wound
- History of stroke
-Grade > 1 peripheral neuropathy (as defined by the NCI CTCAE, v3.0);
-History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study drug administration;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004699-52-NL |
| CCMO | NL51376.056.14 |