Phase 1 Study to Assess Safety, Tolerability, and Drug Behavior of Increasing Single Doses of SK-08 Tablets in Healthy Adults Aged 18 to 45

What this Trial Is About

Researchers are conducting a single-center, randomized, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called SK-08 in healthy adults aged 18 to 45 years. This phase 1 trial involves evaluating seven increasing dose groups, enrolling a total of 48 healthy participants. The study is sponsored by Consun Pharmaceutical Group and focuses on understanding how SK-08 behaves in the body and how well it is tolerated. The trial includes seven sequential dose groups ranging from 5 mg to 60 mg of SK-08 or placebo. Participants receive a single dose of either SK-08 or placebo depending on their assigned group. The doses are given once, and the participants are randomly assigned to either the SK-08 or placebo group in a double-blind manner to ensure unbiased assessment. During the study, participants undergo multiple evaluations including safety assessments up to Day 12, detailed pharmacokinetic measurements at various time points up to 96 hours after dosing, and pharmacodynamic monitoring of heart rate, blood pressure, cGMP concentration levels, and QT interval analysis. These tests help researchers understand the effects and movement of the drug in the body. The overall participation duration covers these monitoring periods, ensuring careful observation of any potential effects or side effects.

A Study to Evaluate the Safety, Tolerability and PK of SK-08