drugset / Trial / NCT07632573

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

NCT07632573 ↗

Phase 1 Recruiting 68 enrolled Benethera (Shaoxing) Biotechnology Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.

Timeline

Start
2026-05-18
Primary completion
2026-12-31
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject BDHK-2009 Unknown — Oral