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Not yet recruitingNCT07593690Updated May 18, 2026

A Phase I Study of HW241045 in Healthy Subjects

A Phase 1 interventional study of HW241045 Formulation A and HW241045 Formulation B in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis (IPF)

Keywords

  • HW241045
  • Idiopathic Pulmonary Fibrosis
  • healthy participants
03

In context

Idiopathic Pulmonary Fibrosis

551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's planned enrollment of 102 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. is the lead sponsor of 8 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    HW241045 Formulation A

    Drug: HW241045 Formulation A

  • Experimental
    HW241045 Formulation B

    Drug: HW241045 Formulation B

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHW241045 Formulation A

    Single-dose administration in Part A.

  • DrugHW241045 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.

  • DrugPlacebo

    Single-dose administration in Part B, with 4 dose groups;Multiple-dose administration in Part C, with 3 dose groups.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the first dose administration to 48 hours after the last dose.

07

Study locations

1 site
  • The First Affiliated Hospital of Shandong First Medical University(Shandong Provincial Qianfoshan Hospital)
    Jinan, Shandong 250014, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07593690
Lead sponsor
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
May 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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