Trials / Completed
CompletedNCT04514796
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adalimumab | SB5 (adalimumab), 40 mg, single-dose |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2021-05-15
- Completion
- 2021-05-15
- First posted
- 2020-08-17
- Last updated
- 2021-05-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04514796. Inclusion in this directory is not an endorsement.