Trials / Completed
CompletedNCT03722329
Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eculizumab | Eculizumab Injection. 300 mg, single dose |
Timeline
- Start date
- 2018-11-13
- Primary completion
- 2019-03-29
- Completion
- 2019-04-08
- First posted
- 2018-10-26
- Last updated
- 2020-01-09
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03722329. Inclusion in this directory is not an endorsement.