NCT06858657

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

A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK,PD and Food Effect of HSK44459 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HSK44459	Dose 1 to Dose 5
DRUG	placebo	dose 1 to dose 5

Timeline

• Start date: 2024-08-17
• Primary completion: 2024-11-18
• Completion: 2024-12-20
• First posted: 2025-03-05
• Last updated: 2025-03-05

Locations

1 site across 1 country: China