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A Phase I Study of HW241045 in Healthy Subjects

NCT07593690 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

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.

Sponsors & Collaborators

  • Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593690 on ClinicalTrials.gov