Phase 1
Completed N=119
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Healthy
Source: ClinicalTrials.gov NCT02453672 ↗
Enrolled (actual)
119
Serious AEs
0.8%
Results posted
Jun 2019
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) — 25354.4; 28896.8; 28684.8 h·μg/mL
Summary
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) |
25354.4; 28896.8; 28684.8 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
24199.2; 27342.2; 27177.9 | — |
| PRIMARY Maximum Serum Concentration (Cmax) |
76.259; 76.059; 76.485 | — |
| SECONDARY Time to Reach Cmax (Tmax) |
3.639; 3.638; 5.646 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects
- Have body weight between 65.0-90.0 kg (inclusive) and body mass index between 20.0-29.9 kg/m2 (inclusive)
Exclusion Criteria
- Have a history of hypersensitivity or allergic reactions to bevacizumab or to any of the excipients
- Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric, or allergic disease excluding mild asymptomatic seasonal allergies
- Have a history of arterial thromboembolic events including cerebrovascular accidents, transient ischaemic attacks, and myocardial infarction
- Have a history of and/or current cardiac disease
- Have previously been exposed to vascular endothelial growth factor (VEGF) antibody, any other antibody, or protein targeting the VEGF receptor
- Have a history of cancer including lymphoma, leukaemia, and skin cancer.
- Have received live vaccine(s) within 30 days prior to Screening visit or who will require a vaccine(s) between Screening and the end of study visit
- Have taken medication with a half-life of > 24 hours within 30 days or 10 half-lives of the medication prior to the IP administration
Data sourced from ClinicalTrials.gov (NCT02453672). 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.