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A Study of PRX004 in Subjects With Amyloid Transthyretin (ATTR) Amyloidosis

NCT03336580 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-08-20

No results posted yet for this study

Summary

A Phase 1, open-label study of intravenous (IV) PRX004 as a single agent in subjects with hereditary amyloid transthyretin (hATTR) amyloidosis. The study will consist of 3 phases and will enroll up to a total of 36 subjects. A 3+3 dose escalation component to determine the safety, tolerability, PK, PD, and MTD. An expansion component in anticipated PRX004 RP2D cohorts selected from the Dose Escalation Phase. An extended dosing component for eligible subjects from the Dose Escalation or Expansion phases.

Conditions

  • Amyloidogenic Transthyretin (ATTR) Amyloidosis

Interventions

DRUG

PRX004

PRX004 (0.1, 0.3, 1, 3, 10, and 30 mg/kg) IV every 28 days PRX004 IV every 28 days at RP2D(s) PRX004 IV every 28 days at RP2D(s)

Sponsors & Collaborators

  • Prothena Biosciences Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2020-07-23
Completion
2020-07-23
FDA Drug
Yes

Countries

  • United States
  • Portugal
  • Spain
  • Sweden

Study Locations

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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 NCT03336580 on ClinicalTrials.gov