drugset / Trial / NCT06858657

A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK44459 in Healthy Subjects

NCT06858657 ↗

Phase 1 Completed 82 enrolled Haisco Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK44459 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.

Timeline

Start
2024-08-17
Primary completion
2024-11-18
Completion
2024-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject HSK44459 Unknown — Oral

Indications

No indication recorded.