Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05648214
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2022-12-05
Brief Title:
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Non-Alcoholic Fatty Liver Disease NAFLD
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Two-Part Phase 1 Randomized Double-blind Placebo-Controlled Single Dose Study of the Safety Tolerability and Pharmacokinetics of ALN-PNP an siRNA Targeting PNPLA3 in Healthy Adults and Adult Participants With NAFLD
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental drug called ALN-PNP called study drug This is a first in human study The study drug is not approved by any public health agency such as the United States Food and Drug Administration FDA for any kind of treatment
Part A is focused on healthy participants Part B of the study is focused on participants who are known to have NAFLD and a specific variant of the PNPLA3 gene The aim of the study is to see how safe tolerable and effective the study drug is
Part A is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the study drug less effective or could lead to side effects
Explore impact of Japanese ethnicity on safety and PK pharmacokinetics or study of what the body does to the drug of single doses of ALN-PNP over time
Part B is looking at several other research questions including
What side effects may happen from taking the study drug
How the study drug works to change liver fat content in NAFLD
How much study drug and study drug metabolites byproduct of the body breaking down the study drug are in your blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Better understanding of the study drug and NAFLD
Part A is focused on healthy participants Part B of the study is focused on participants who are known to have NAFLD and a specific variant of the PNPLA3 gene The aim of the study is to see how safe tolerable and effective the study drug is
Part A is looking at several other research questions including
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the study drug less effective or could lead to side effects
Explore impact of Japanese ethnicity on safety and PK pharmacokinetics or study of what the body does to the drug of single doses of ALN-PNP over time
Part B is looking at several other research questions including
What side effects may happen from taking the study drug
How the study drug works to change liver fat content in NAFLD
How much study drug and study drug metabolites byproduct of the body breaking down the study drug are in your blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Better understanding of the study drug and NAFLD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None