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First-in-Human Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy

NCT04360434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-11-03

No results posted yet for this study

Summary

A phase 1, randomized, placebo-controlled, double-blind, dose escalation trial combining single-ascending dose and multiple-ascending dose phases of NI006 or placebo, followed by an open-label extension phase in subjects with Amyloid Transthyretin Cardiomyopathy (ATTR-CM).

Conditions

  • Amyloid Transthyretin Cardiomyopathy

Interventions

DRUG

NI006

NI006 will be administered intravenously

DRUG

Placebo

Formulation buffer of NI006, matching volume of NI006 doses will be administered intravenously

Sponsors & Collaborators

  • Neurimmune AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2023-07-26
Completion
2023-07-26

Countries

  • France
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT04360434 on ClinicalTrials.gov