A Phase I Study of HW241045 in Healthy Subjects

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: HW241045 Formulation A; Drug: HW241045 Formulation B; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • The First Affiliated Hospital of Shandong First Medical University(Shandong Provincial Qianfoshan Hospital)
      • Contact: Wei Zhao; Phone Number: 0531-89268212; Email: zhao4wei2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• The study participant is able to communicate well with the investigator, understand and comply with all requirements of the study, fully comprehend the purpose, nature and methodology of the trial as well as potential adverse reactions, and sign the informed consent form prior to initiation of any study procedures.
• Healthy male and female study participants aged 18 to 45 years (inclusive).
• Female study participants shall have a body weight ≥ 45 kg, male study participants ≥ 50 kg; body mass index (BMI) ranges from 19 to 26 kg/m² (inclusive).

Key Exclusion Criteria:

• Any study participant with a past or current clinically severe or chronic disease involving the circulatory, endocrine, nervous, digestive, respiratory, hematologic, or immune system, as well as psychiatric disorders and metabolic abnormalities; or with any other disease deemed by the investigator likely to interfere with the trial results.
• Participants with a history of gastrointestinal, hepatic or renal diseases that may affect drug absorption or metabolism, or with known or suspected diseases that may interfere with drug intake, transportation, absorption, distribution, metabolism or excretion.
• Participants with a history of drug or food allergy, allergic diseases, or allergic constitution (allergic to two or more substances), or with a confirmed allergy to any component of the study drug.
• Participants who have used any drugs that inhibit or induce hepatic drug metabolism within 30 days prior to the trial or during the trial period.
• Participants with any other factors deemed unsuitable for participation in the clinical study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single-dose administration in Part B, with 4 dose groups；Multiple-dose administration in Part C, with 3 dose groups.
Experimental: HW241045 Formulation A	Drug: HW241045 Formulation A; Single-dose administration in Part A.
Experimental: HW241045 Formulation B	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number and severity of treatment emergent adverse events (TEAEs)	To assess the safety and tolerability of single or multiple oral dose of HW241045 in healthy participants.	From the first dose administration to 48 hours after the last dose.

Collaborators and Investigators

• Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis; healthy participants; HW241045
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: HW241045-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No