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

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 - Single dose study of ONS-1045 in healthy male volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41859

Enrollment

135

Registered

2014-12-01

Start date

2014-12-22

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

A single dose of 2 mg/kg ONS-1045, EU-licensed Avastin® or US-licensed Avastin® will be administered

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy Male subjects - Age >=18 and

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)