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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2022
  • participants needed
    36
  • sponsor
    Neurimmune AG
Updated on 30 June 2021

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).

Description

This phase 1, randomized, placebo-controlled, double-blind trial in subjects with Amyloid Transthyretin Cardiomyopathy (ATTR-CM) consists of single-ascending dose (SAD) and multiple-ascending dose (MAD) phases, followed by an open-label extension (OLE) phase.

In the SAD phase subjects are randomized in a 4:2 ratio to receive a single infusion of NI006 or placebo.

Subjects completing the SAD phase will be enrolled in the MAD phase upon evaluation of all available safety data and receive a maximum of 3 additional infusions of NI006 or placebo every 28 days.

Subjects completing the MAD phase will have the possibility to continue in an OLE phase with treatment up-titrations and switch from placebo to NI006 and receive up to 8 infusions of NI006 every 28 days.

In the dose escalation about 30 to 36 subjects are planned to be enrolled in 5 to 6 ascending dose cohorts of 6 subjects each.

Details
Condition Amyloid Transthyretin Cardiomyopathy
Treatment Placebo, NI006
Clinical Study IdentifierNCT04360434
SponsorNeurimmune AG
Last Modified on30 June 2021

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