NCT01323985

SAP Depleter Dose Escalation Study in Healthy Volunteers

A Phase 1 Dose Escalation Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Intravenous Doses of GSK2315698A in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to provide safety information and to define the optimal induction and short term maintenance regimen for GSK2315698 to deplete circulating SAP in healthy volunteers prior to assessing in patients

Detailed description

This single centre, open label, dose escalation study is designed to assess safety (including adverse events, vital signs, ECGs, and clinical laboratory tests), and pharmacokinetic /pharmacodynamic parameters in healthy volunteers. Subjects will attend for 3 sessions: session 1 is a single intravenous (IV) infusion over a short time period to confirm the safety of a single dose of GSK2315698 over a wide dose range, sessions 2 and 3 will investigate IV infusion regimens over 24 hours (induction phase followed by maintenance phase). The dosing regimen will be adjusted adaptively to optimise the induction and maintenance phases of the dosing regimen. amyloidosis.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	GSK2315698	5mg-400mg IV (in the vein) single dose over 1-4 hours
DRUG	GSK2315698	IV (in the vein) single dose over 24 hours, in two sessions

Timeline

• Start date: 2011-01-06
• Primary completion: 2011-06-30
• Completion: 2011-06-30
• First posted: 2011-03-28
• Last updated: 2017-07-21

Locations

1 site across 1 country: United Kingdom