MedTrace Logo

Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

NCT01707264 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2018-08-28

No results posted yet for this study

Summary

Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.

Conditions

  • Primary Amyloidosis

Interventions

DRUG

NEOD001

Monoclonal antibody administered by intravenous infusion every 28 days.

Sponsors & Collaborators

  • Prothena Biosciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Julia Martinisi · Prothena Biosciences Ltd.

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-08-09
Completion
2016-08-09

Countries

  • United States

Study Locations

More Related Trials

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 NCT01707264 on ClinicalTrials.gov