A RANDOMIZED, SINGLE DOSE, DOUBLE BLIND, PARALLEL GROUP, PHARMACOKINETIC TRIAL, COMPARING ONS-1045 (ONCOBIOLOGICS INC, USA) TO 2 ARMS OF AVASTIN® (GENENTECH, SOUTH SAN FRANCISCO, USA; ROCHE, SWITZERLAND) IN HEALTHY MALE VOLUNTEERS

Completed

• Conditions: Cancer; 10027656

• Registration Number: NL-OMON41859
• Lead Sponsor: Oncobiologics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 135

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the following pharmacokinetic parameter:<br /><br><br /><br>• AUC0-* and ratio of the geometric least square means of test to reference<br /><br>products and its associated 90% confidence interval</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary pharmacokinetic endpoints include:<br /><br>• Other pharmacokinetic parameters derived from serum samples including AUC0-t,<br /><br>Cmax, Tmax, kel, t1/2el, clearance (CL), and Vd<br /><br><br /><br>Safety endpoints include:<br /><br>• Adverse events (AE).<br /><br>• Clinical laboratory and vital signs.<br /><br>• Immunogenicity assessments.</p><br>