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NOT YET RECRUITING
NCT07593690
PHASE1

A Phase I Study of HW241045 in Healthy Subjects

Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

HW241045 Formulation A

Single-dose administration in Part A.

DRUG

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.

DRUG

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