SAP Depleter Dose Assessment Study in Patients
NCT01406314 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2017-06-09
Summary
This study aims to provide safety information on the ligand, GSK2315698A. The pharmacokinetics and pharmacodynamics of the ligand will be determined together with the differences in routes of dose administration, namely the tolerability between intravenous versus subcutaneous dose administration. The study will be carried out in patients with systemic amyloidosis and the ability of GSK2315698A in depleting levels of serum amyloid protein (SAP) will be measured.
Conditions
- Amyloidosis
Interventions
- DRUG
-
GSK2315698
Intravenous infusion for approximately 48hours followed by subcutaneous injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-13
- Primary Completion
- 2012-11-14
- Completion
- 2012-11-14
Countries
- United Kingdom
Study Locations
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