NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
A Double-blind, Sponsor-Open, Placebo-controlled, Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of HU6 in High BMI Volunteers
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe.
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe. Double-blind dosing will occur in cohorts 1 through 4. In these cohorts, 8 subjects will receive HU6 and 2 will receive matching placebo. Doses will escalate and may be modified based on results of safety and pharmacokinetic evaluation conducted after each cohort. ;
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