SAP Depleter Dose Assessment Study in Patients

NCT01406314 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-06-09

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406314 on ClinicalTrials.gov