Phase 1
Completed N=109
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Healthy
Source: ClinicalTrials.gov NCT02075073 ↗
Enrolled (actual)
109
Serious AEs
0.9%
Results posted
Sep 2016
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) — 34783.4; 35889.9; 37370.3 µg·h/mL
Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) |
34783.4; 35889.9; 37370.3 | — |
| PRIMARY Maximum Serum Concentration (Cmax) |
154.224; 153.479; 155.513 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
34320.8; 35367.5; 36690.4 | — |
| SECONDARY Time to Cmax (Tmax) |
4.691; 3.529; 2.799 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects
- Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and 29.9 kg/m², inclusive.
Exclusion Criteria
- history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or significant allergic disease excluding mild asymptomatic allergies.
- history of and/or current cardiac disease
- previously received any monoclonal antibody or fusion protein.
- history of cancer including lymphoma, leukaemia and skin cancer.
- Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
- intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.
Data sourced from ClinicalTrials.gov (NCT02075073). 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.