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In this randomized, double-blind, placebo-controlled, single-dose and multi-dose incremental Phase I clinical study, 65 subjects with non-alcoholic fatty liver disease (NAFLD) characteristics with low-density lipoprotein cholesterol (LDL-C) greater than 110 mg/dL were studied, and the experimental drug was a commercially produced ASC41 tablet using the proprietary agent technology of Ganle.
In the single-dose incremental study, as the dose ranged from 1 mg to 20 mg, the amount of drug exposure (pharmacodynamics) in ASC41 was linear and showed good safety and tolerance in dose groups up to 20 mg.
In a multi-dose incremental clinical study, after 14 days of daily oral TREATMENT of ASC41 tablets, the LDL-C and triglyceride (TG) indicators of the subjects showed clinical significance and statistically significant reductions relative to the placebo group, as shown in the table below: In 14 days of treatment, ASC41 did not have class 3 or above adverse events, adverse events or early on-stop events in all dosage groups.
in a 14-day daily oral study of ASC41 tablets, the amount of drug exposure (pharmacodynamics) in ASC41 tablets was linearized with the dose of the drug from 1 mg to 5 mg.
note: There are deletions in the original text
