First-in-Human Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy
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- STATUS
- Recruiting
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- End date
- Feb 28, 2023
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- participants needed
- 36
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- sponsor
- Neurimmune AG
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.
Subjects of cohort 1 to 5 who received at least one dose of NI006 during the OLE phase will have the possibility for a second OLE phase (OLE2) after completing the OLE phase and receive up to 10 additional infusions of NI006 every 28 days.
In total, 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 Identifier | NCT04360434 |
| Sponsor | Neurimmune AG |
| Last Modified on | 21 April 2022 |
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