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NCT01323985

SAP Depleter Dose Escalation Study in Healthy Volunteers

Completed Phase 1 Last updated 21 July 2017
What this trial tests

Phase 1 trial testing GSK2315698 in Amyloidosis in 21 participants. Completed in 30 June 2011.

Timeline
6 January 2011
Primary endpoint
30 June 2011
30 June 2011

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date6 January 2011
Primary completion30 June 2011
Estimated completion30 June 2011
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis.
    Nuvolone M, Nevone A, Merlini G. · · 2022 · cited 23× · PMID 36094752 · DOI 10.1007/s40259-022-00550-w
  2. Target Mediated Drug Disposition Model of CPHPC in Patients with Systemic Amyloidosis.
    Sahota T, Berges A, Barton S, Cookson L, et al · · 2015 · cited 9× · PMID 26225229 · DOI 10.1002/psp4.15

Verify or expand the search:

Other trials of GSK2315698

Trials testing the same drug.

Other recruiting trials for Amyloidosis

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01323985.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing