CClinicalTrials.gg
Not yet recruitingNCT07728721IPFUpdated Jul 27, 2026

Evaluating the Efficacy and Safety of of HSK50042 in People With Idiopathic Pulmonary Fibrosis

A Phase 2 interventional study of HSK50042 dose 1 and HSK50042 dose 2 in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Haisco Pharmaceutical Group Co., Ltd.. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis (IPF)
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 175 is above the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

1. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:

  1. IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
  2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.

2. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb]) ≥ 25% and\<90% of predicted normal at screening period.

4. Patients have to be either:

  1. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy.
  2. on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the screening period.

Exclusion criteria

Exclusion Criteria:

  1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at screening.
  2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  3. Acute IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined).
  4. History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.).
  5. Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed).
  6. Uncontrolled hypertension at screening or prior to randomization/investigational product administration (defined as refractory hypertension as assessed by the investigator, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg); or hypotension (seated systolic blood pressure \<100 mmHg or diastolic blood pressure \<60 mmHg).
  7. Administration of systemic corticosteroids equivalent to >15 mg prednisone per day within 4 weeks prior to screening and/or during the screening period.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
175 participants (estimated)

Study arms

  • Experimental
    HSK50042-dose 1

    HSK50042 taken orally once daily in the morning for 26 weeks.

    Drug: HSK50042 dose 1

  • Experimental
    HSK50042-dose 2

    HSK50042 taken orally once daily in the morning for 26 weeks.

    Drug: HSK50042 dose 2

  • Experimental
    HSK50042-dose 3

    HSK50042 taken orally once daily in the morning for 26 weeks.

    Drug: HSK50042 dose 3

  • Experimental
    Placebo

    Placebo matching HSK50042 taken orally once daily in the morning for 26 weeks.

    Drug: Placebo

Interventions

  • DrugHSK50042 dose 1

    HSK50042 taken orally once daily in the morning for 26 weeks.

  • DrugHSK50042 dose 2

    HSK50042 taken orally once daily in the morning for 26 weeks.

  • DrugHSK50042 dose 3

    HSK50042 taken orally once daily in the morning for 26 weeks.

  • DrugPlacebo

    Placebo matching HSK50042 taken orally once daily in the morning for 26 weeks.

06

What researchers measure

Primary outcomes

  1. The change from baseline in forced vital capacity (FVC) at week 12

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness

    Time frame: week 12

Secondary outcomes

  1. The change from baseline in forced vital capacity (FVC) at week 26

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness

    Time frame: week 26

  2. The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12/26

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness

    Time frame: week12/26

07

Study locations

No study locations are listed for this record.

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 Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07728721
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Aug 25, 2026 (estimated)
Primary completion
Apr 10, 2028 (estimated)
Completion
Jul 25, 2028 (estimated)
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
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 Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion