Clinical Trial: A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Healthy
Study Type: INTERVENTIONAL
Official Title: A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single and Multiple Doses of ENC1018 in Healthy A
Brief Summary:
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and PK characteristics of ENC1018 after single and multiple oral dose administration in healthy adult subjects.The study will be conducted in two parts: Part A -Single ascending Dose (SAD) and Part B - Multiple ascending dose (MAD).A Food Effect Cohort will be conducted within Part A. Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days.Approximately 72 healthy…
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