Phase 1 Study to Assess Safety, Tolerability, and Drug Behavior of Single and Multiple Oral Doses of SK-09 in Healthy Adults

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study SK-09, a drug being evaluated in healthy adult volunteers. The study is divided into two parts Part 1 assesses single ascending doses SAD while Part 2 tests multiple ascending doses MAD. Both parts use a randomized, double-blind, placebo-controlled design to examine safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD. In Part 1, six dose levels of SK-09 tablets 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg are given as single oral doses. Part 2 includes three dose groups for multiple oral doses based on Part 1 results low dose 100 mg twice daily, medium dose 200 mg twice daily, and high dose 500 mg once daily or 300 mg twice daily. Placebo groups are included in both parts for comparison. Participants are healthy adults aged 18 to 55 years with body weight of at least 50 kg and BMI between 18.5 and 29.9. They will be monitored for safety up to 8 days after single doses and 14 days after multiple doses. Researchers will evaluate blood levels of the drug PK up to 72 hours or 10 days post-dosing and assess drug effects PD within 12 hours on dosing days. The trial includes regular lab tests, vital sign checks, and questionnaires to track tolerability and side effects throughout the study period.

A Study to Evaluate the Safety, Tolerability and PK of SK-09