Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
- Registration Number
- NCT04514796
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Brief Summary
This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 188
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40 mg/0.8 mL of SB5 Adalimumab 50 mg/mL of SB5 40 mg/0.4 mL of SB5 Adalimumab 100 mg/mL of SB5
- Primary Outcome Measures
Name Time Method AUCinf Day 1 to Day 57 Area under the concentration-time curve from time zero to infinity
Cmax Day 1 to Day 57 Maximum serum concentration
- Secondary Outcome Measures
Name Time Method Tmax Day 1 to Day 57 Time to reach Cmax
Vz/F Day 1 to Day 57 Apparent volume of distribution during the terminal phase
%AUCextrap Day 1 to Day 57 Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity
AUClast Day 1 to Day 57 Area under the concentration-time curve from time zero to the last quantifiable concentration
Incidence of treatment-emergent adverse events (TEAEs) Day 1 to Day 57 Experience at least 1 TEAE
λz Day 1 to Day 57 Terminal rate constant
t1/2 Day 1 to Day 57 Terminal half-life
Incidence of serious adverse events (SAEs) Day 1 to Day 57 Experience at least 1 SAE
CL/F Day 1 to Day 57 Apparent total body clearance
Incidence of neutralising antibodies (NAbs) Day 1 to Day 57 Incidence of NAbs to adalimumab
Incidence of anti-drug antibodies (ADAs) Day 1 to Day 57 Incidence of ADAs to adalimumab
Trial Locations
- Locations (1)
Parexel International GmbH, Early Phase Clinical Unit Berlin
🇩🇪Berlin, Germany