A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 13, 2013

Primary Completion Date

December 22, 2015

Study Completion Date

December 22, 2015

Conditions
Amyloidosis
Interventions
DRUG

GSK2398852

Unit dose strength: 100 mg/mL provided as 1 mL solution per vial. GSK2398852 dosage levels variable with the proposed starting dose level of GSK2398852 as 5 mg \[approximately equivalent to 0.1 mg/ kg\]. The next escalation dose levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg.

DRUG

GSK2315698

Unit dose strength: 200 mg/mL stock to be diluted. GSK2315698 will be administered at variable dosed until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 ng/mL.

Trial Locations (2)

CB2 2GG

GSK Investigational Site, Cambridge

SE1 1YR

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Imperial College London

OTHER

collaborator

Heart Hospital

UNKNOWN

collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

collaborator

Quintiles, Inc.

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT01777243 - A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis | Biotech Hunter | Biotech Hunter