Phase 1
Completed N=159
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01922336 ↗
Enrolled (actual)
159
Serious AEs
1.3%
Results posted
Feb 2019
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) — 38702.8145; 39359.7493; 39270.1707 h·μg/mL
Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) |
38702.8145; 39359.7493; 39270.1707 | — |
| PRIMARY Maximum Serum Concentration (Cmax) |
126.9975; 126.2377; 129.1508 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
36862.4180; 37022.3524; 37367.5577 | — |
| SECONDARY Time to Cmax (Tmax) |
2.9294; 2.5824; 2.7591 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy female subjects of non-childbearing potential and healthy male subjects
- Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.
Exclusion Criteria
- history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
- active or latent Tuberculosis or who have a history of Tuberculosis.
- history of invasive systemic fungal infections or other opportunistic infections
- systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
- serious infection associated with hospitalisation and/or which required intravenous antibiotics
- history of and/or current cardiac disease
- have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final 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 (NCT01922336). 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.