At a glance
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A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Food Effect After Single and Multiple Oral Doses of ARTS-011 In Chinese Health Subjects
In Brief
A Phase 1 clinical trial evaluating ARTS-011 and Placebo for Chinese Healthy Volunteer. Completed, enrolled 76 participants across 1 site.
Detailed Summary
This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers.
Study Details
Timeline
Interventions
Single ascending dose (SAD): 3mg, 10mg, 20mg, 40mg, and 60mg. Multiple ascending dose (MAD): 10mg QD, 20mg QD, and 40mg QD X 7 days. Food effect study: single dose of ARTS-011 under the fasting and high-fat meal.
Multiple ascending dose (MAD): 10mg QD, 20mg QD, and 40mg QD X 7 days. Multiple ascending dose (MAD): 10mg QD, 20mg QD, and 40mg QD X 7 days.