Safety and Tolerability Study of SNH-119014 in Healthy Adults Aged 18 to 45

What this Trial Is About

Researchers are studying SNH-119014, an oral small-molecule drug that targets the pyruvate kinase red blood cell isozyme PKR, to understand its safety, tolerability, and how the body absorbs and responds to it. This phase 1 trial involves healthy adult volunteers to gather initial information about the drugs effects and how food influences its absorption. The study involves giving participants either single ascending doses or multiple ascending doses of SNH-119014 or a placebo in a randomized, controlled manner. The treatment is administered orally, and the study uses a quadruple-masked design to compare effects without bias. Participants will undergo regular monitoring including physical examinations, vital signs checks, ECGs, and laboratory tests to detect any abnormal findings or adverse events related to the study drug. The primary outcome focuses on safety measures up to 7 or 20 days after dosing. The total participation duration and follow-up are designed to ensure thorough assessment of drug effects and safety in healthy adults aged 18 to 45 years.

A Phase I Study of SNH-119014 in Healthy Volunteers