Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of BDHK-2009 Tablets in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are conducting a Phase 1, two-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of BDHK-2009 tablets in healthy adult participants. This first-in-human trial aims to assess single ascending oral doses and multiple oral doses of BDHK-2009 in adults aged 18 to 55 years. The study is sponsored by Benethera Shaoxing Biotechnology Co., Ltd. and focuses on gathering initial safety and drug behavior data in the body. Participants will be assigned randomly to receive either BDHK-2009 tablets or placebo. In Part 1 SAD, participants receive a single dose of the study drug or placebo, including a special cross-over period to assess the effect of a high-fat meal on the drugs pharmacokinetics. Part 2 MAD involves multiple ascending doses with three cohorts of eight healthy subjects each, randomized in a 31 ratio to receive BDHK-2009 or placebo once daily. Treatments are given orally, and the study includes a placebo comparator group. During the study, participants will undergo physical exams, vital sign checks, ECGs, and laboratory tests to monitor safety and drug effects from enrollment until four weeks after treatment begins. Researchers will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of BDHK-2009, including the impact of food intake on drug absorption. The study requires adherence to visit schedules and monitoring to ensure participant safety and accurate data collection.

A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult