Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT07909655
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing HB0056 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- HB0056
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 biopsy or surgical/thoracoscopic lung biopsy)；
- FVCpp ≥ 45% during screening period and the first day;
- The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30%;
- pre-bronchodilator forced expiratory volume in 1 second (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；
Who cannot join
- 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 investigational 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xiangya Third Hospital of Central South University
Changsha, Hunan, 410000
jie meng, 86-13607492399, mj0377@163.com
Fudan University Affiliated Zhongshan Hospital
Shanghai, 200100
qunying hong, Doctor, 86-13816880830, qyhong68@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Treatment of Idiopathic Pulmonary Fibrosis Patients With HB0056
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- HB0056, Placebo
- Keywords
- HB0056, Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0056Drug
subjects be given HB0056 high dose
HB0056Drug
subjects be given HB0056 low dose
PlaceboDrug
subjects be given placebo during the first 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| HB0056 group 1 | Experimental | Not described Receives: Drug: HB0056 |
| HB0056 group 2 | Experimental | Not described Receives: Drug: HB0056 |
| control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
Measured: 24 weeks
Secondary outcomes (1)
Change from Baseline in FVC% (Percent of Predicted FVC value)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Shanghai Huaota Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuojun Xu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909655
- Sponsor's protocol ID
- HB0056-IPF-02-01
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Treatment of Idiopathic Pulmonary Fibrosis Patients With HB0056
- ClinicalTrials.gov ID
- NCT07909655
- Acronym / sponsor ID
- HB0056-IPF-02-01
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- HB0056, Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HB0056 group 1 | Experimental | Drug: HB0056 |
| HB0056 group 2 | Experimental | Drug: HB0056 |
| control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 biopsy or surgical/thoracoscopic lung biopsy)；
- FVCpp ≥ 45% during screening period and the first day;
- The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30%;
Key exclusion criteria (6 listed)
- 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 investigational drugs within 28 days prior to screening or within 5 half lives of the drug (whichever is longer);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB0056subjects be given HB0056 high dose | Drug | HB0056 group 1 |
| HB0056subjects be given HB0056 low dose | Drug | HB0056 group 2 |
| Placebosubjects be given placebo during the first 24 weeks | Drug | control group |
Primary outcome
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
Time frame: 24 weeks
1 secondary outcome
Change from Baseline in FVC% (Percent of Predicted FVC value)
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuojun Xu principal investigator
Peking Union Medical College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB0056 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuojun xu (86-13671345136, xuzuojun123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.