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A Phase I Study of HW241045 in Healthy Subjects
Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Summary
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW241045 in healthy participants. This study consists of three parts:1)Part A: A single-dose, two-period, two-way crossover design to evaluate the safety and pharmacokinetic differences between Formulation A and Formulation B of HW241045 tablets; 2)Part B: A single-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B following single administration. A food-effect study is nested within this part.3)Part C: A multiple-dose ascending dose design to evaluate the safety, tolerability, and pharmacokinetic profiles of HW241045 Formulation B after multiple administrations.
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HW241045 Tablets After Single and Multiple Dosing in Healthy Study Participants.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-06
Completion Date
2027-01
Last Updated
2026-05-18
Healthy Volunteers
Yes
Conditions
Interventions
HW241045 Formulation A
Single-dose administration in Part A.
HW241045 Formulation B
Single-dose administration in Part A;Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups.
Placebo
Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups.
Locations (1)
The First Affiliated Hospital of Shandong First Medical University(Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, China