CClinicalTrials.gg
RecruitingNCT07448194Updated Mar 4, 2026

A Phase Ia Clinical Trial of HW241045

A Phase 1 interventional study of HW241045 and Placebo in Healthy Volunteers and IPF, sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.

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

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Nov 2025, registered Feb 2026).
  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a Phase Ia, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetic (PK) of HW241045 in healthy subjects following a single ascending dose.

02

Conditions studied

  • Healthy Volunteers
  • IPF

Keywords

  • HW241045
  • healthy volunteers
  • Safety
  • Pharmacokinetics
03

In context

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 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • The subjects have been fully informed of the trial's purpose, nature, methodology, and potential adverse reactions. They voluntarily participate in the trial and sign the informed consent form prior to the initiation of any study procedures;
  • Healthy male and female subjects aged 18 to 55 years;
  • Female subjects must have a body weight of ≥ 45 kg and male subjects ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m².

Key Exclusion Criteria:

  • Subjects with a history of or current severe clinical disease involving any of the following systems: circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, mental, or metabolic systems; or subjects with any other disease that the investigator judges may interfere with the study results;
  • Subjects with a history of severe trauma or major surgery within 3 months prior to screening; or subjects planning to undergo surgery during the trial period or within two weeks after study completion;
  • Subjects with a history of gastrointestinal, hepatic, or renal diseases that affect drug absorption or metabolism; or those with conditions known or suspected to interfere with drug ingestion, transport, absorption, distribution, metabolism, or excretion;
  • Subjects with clinically significant abnormalities in any screening test results as judged by the investigator;
  • Subjects with a history of drug or food allergy, allergic disorders, or atopic diathesis; or those with confirmed hypersensitivity to any component of the investigational drug;
  • Subjects with difficult venous blood collection, or whose physical condition cannot tolerate intensive blood sampling;
  • Not suitable for this study as judged 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
56 participants (estimated)

Study arms

  • Experimental
    HW241045

    Single oral dose of HW241045

    Drug: HW241045

  • Placebo comparator
    Placebo

    Single oral dose of Placebo

    Drug: Placebo

Interventions

  • DrugHW241045

    Dose 1 to Dose 7

  • DrugPlacebo

    Dose 1 to Dose 7

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 oral dose of HW241045 in healthy adult volunteers

    Time frame: Up to 48 hours

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, 100730, China
    Recruiting
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 Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07448194
Lead sponsor
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Nov 24, 2025
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Mar 4, 2026

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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