Genoma Research Group, Inc. | Miami, FL
Status and phase
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About
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:
Part B is looking at several other research questions, including:
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Part A (Healthy Adults):
From 18 to 55 years of age
For Japanese cohorts ONLY; the Japanese participant must:
Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
Is judged by the investigator to be in good health, as described in the protocol
Is in good health based on laboratory safety testing obtained at the screening visit and approximately within 24 hours prior to administration of study drug
Part B (Participants with NAFLD):
Key Exclusion Criteria:
Part A:
Part B:
NOTE: Other protocol defined inclusion / exclusion criteria apply
Primary purpose
Allocation
Interventional model
Masking
96 participants in 12 patient groups, including a placebo group
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Central trial contact
Clinical Trials Administrator
Data sourced from clinicaltrials.gov
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