Phase 1
Completed N=189
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT02144714 ↗
Enrolled (actual)
189
Serious AEs
1.1%
Results posted
Sep 2018
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) — 2405.6; 2435.5; 2422.6 μg·h/mL
Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) |
2405.6; 2435.5; 2422.6 | — |
| PRIMARY Maximum Serum Concentration (Cmax) |
3.365; 3.548; 3.488 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
2125.7; 2096.0; 2101.9 | — |
| SECONDARY Time to Cmax (Tmax) |
165.962; 149.715; 166.456 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects
- Have 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 investigational product 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 4 weeks 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 4 weeks or 10 half-lives of the medication prior to investigational product administration
Data sourced from ClinicalTrials.gov (NCT02144714). 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.