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Not yet recruitingNCT07909655Updated Nov 2, 2026

A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 2 interventional study of HB0056 and HB0056 in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

This trial is a 58 week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of HB0056, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis (IPF)

Keywords

  • HB0056
  • Idiopathic Pulmonary Fibrosis
03

In context

Idiopathic Pulmonary Fibrosis

576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.

This study's planned enrollment of 75 is above the median of 55 across 389 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd. is the lead sponsor of 19 studies on the registry; 14 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Age 40 to 80, inclusive, at the time of screening
  • IPF diagnosed within 5 years prior to screening，and whose HRCT during the screening period meets the diagnostic guidelines for idiopathic pulmonary fibrosis jointly released by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT) in 2022
  • HRCT diagnosis UIP type/possible UIP type (standard HRCT confirmed by central review in recent 3 months) with or without pathological UIP type/possible UIP type (pathology refers to frozen lung or surgical/thoracoscopic lung biopsy)；
  • FVCpp ≥ 45% during screening period and the first day;
  • The percent of predicted DLCO value (corrected by value) at screening is ≥ 30%;
  • pre-bronchodilator (FEV1)/forced vital capacity (FVC) ≥ 0.7
  • Before randomization, pirfenidone or nidanib with stable dose ≥ 8 weeks can continue to maintain treatment with stable dose during the study period; Or at least 8 weeks before randomization, pirfenidone or nidanib was not used；

Key Exclusion Criteria:

  • Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within 3 months prior to screening and/or during the screening period (investigator-determined).
  • Received experimental treatment for IPF within the first 4 weeks of randomization;
  • Individuals who have received treatment with Namistat or other PDE4 inhibitors within the first 8 weeks of randomization or plan to receive treatment with Namistat or other Phosphodiesterase-4(PDE4) inhibitors during the study period;
  • Those who have used prednisone>15mg/day or equivalent dose within the first 2 weeks of randomization and require maintenance;
  • Have participated in any clinical trials of drugs within 28 days prior to screening or within 5 half lives of the drug (whichever is longer);
  • Acute respiratory or systemic bacterial, viral, or fungal infections requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

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

Study arms

  • Experimental
    HB0056 group 1

    Drug: HB0056

  • Experimental
    HB0056 group 2

    Drug: HB0056

  • Placebo comparator
    control group

    Drug: Placebo

Interventions

  • DrugHB0056

    subjects be given HB0056 high dose

  • DrugHB0056

    subjects be given HB0056 low dose

  • DrugPlacebo

    subjects be given placebo during the first 24 weeks

06

What researchers measure

Primary outcomes

  1. Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24

    Time frame: 24 weeks

Secondary outcomes

  1. Change from Baseline in FVC% (Percent of Predicted FVC value)

    Time frame: 52 weeks

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07909655
Lead sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Zuojun xu
Contact
xuzuojun123@126.com
86-13671345136
Zuojun Xu
principal investigator · Peking Union Medical College Hospital

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 Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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