AsthmaPhase 1/2NCT07899996
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
A Phase 1/2 study testing HB0056 in people with Asthma, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The goal of this clinical trial is to learn if drug HB0056 works to treat severe asthma in adults. It will also learn about the safety of drugHB0056. The main questions it aims to answer are: Does drug HB0056 lower the number of times participants need to use a rescue inhaler? What medical problems do participants… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- HB0056
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 21 Aug 2025to 1 Aug 2028
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18-75 years (inclusive) [as of the date of signing the informed consent form (ICF)];
- Body weight≥ 40 KG and body mass index is between 18-40 kg/m2;
- Diagnosis of asthma with a medical history of at least 1 year;
- Those who have received a moderate-to-high dose of ICS (≥ 250 μg fluticasone propionate dry powder formulation equivalent total daily dose) for ≥ 3 consecutive months prior to screening, combined with at least one asthma control drug that has been maintained a stable treatment regimen and dose for ≥ 1 month prior to screening;
- At least 1 asthma exacerbation within 12 months prior to screening;
- 40% ≤ FEV1 < 80% of predicted normal value pre-bronchodilator at screening;
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- There is a record of reversibility test result of FEV1 ≥ 12% and ≥ 200 mL within 12 months prior to randomization, or the reversibility test result meets FEV1 ≥ 12% and ≥ 200 mL at screening;
- ACQ-6 score ≥1.5 prior to randomization;
- No birth planning and voluntarily use effective contraception throughout the study until 6 months after the last dose;
Who cannot join
- Clinically significant lung diseases other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity hypoventilation syndrome, lung cancer, α1-antitrypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases other than asthma that results in peripheral blood eosinophil count increased (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
- Any disease judged as unstable by the investigator, including but not limited to unstable cardiovascular, gastrointestinal, hepatic, renal, nervous system, musculoskeletal, infectious, endocrine, metabolic, hematological, and psychiatric diseases or major physical injury.
- Subjects with current or a history of cancer (except skin squamous cell carcinoma in situ, basal cell carcinoma or cervical carcinoma in situ without any signs of recurrence for more than 5 years after complete response following radical treatment);
- History of clinically significant infection within 14 days prior to screening, which includes upper respiratory tract infection (URTI) and lower respiratory tract infection (LRTI), requiring antibiotic or antiviral treatment;
- Major surgery within 8 weeks prior to screening or planned surgery requiring general anaesthesia or hospitalization for > 1 day during the study period;
- Helminth parasite infection diagnosed within 6 months prior to screening, not receiving or responding to standard of care;
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- Current smoker or quit smoking less than 6 months ago at screening, or with a history of smoking ≥ 10 pack-years (Note: 1 pack = 20 cigarettes, 10 pack-years = 1 pack/day * 10 years, or 1/2 pack/day * 20 years);
- Subjects with a history of alcoholism or drug abuse or dependence.
- Those with active tuberculosis infection or latent tuberculosis requiring treatment at screening;
- Those who are allergic or intolerant to components of HB0056 injection or placebo or have a history of severe drug allergy or anaphylactic shock;
- Subjects who are considered inappropriate to participate in this clinical trial by the investigator.
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, 2 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Su Nan, PHD, +86-10-84205566, sunan7632@163.com
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Li Jingtong, PHD, +86-10-84205566, gcpljt@189.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of HB0056 in Adult Participants With Moderate to Severe Asthma
The goal of this clinical trial is to learn if drug HB0056 works to treat severe asthma in adults. It will also learn about the safety of drugHB0056. The main questions it aims to answer are:
Does drug HB0056 lower the number of times participants need to use a rescue inhaler? What medical problems do participants have when taking drug HB0056? Researchers will compare drug HB0056 to a placebo to see if drug HB0056 works to treat severe asthma.
Participants will:
Take drug HB0056 or a placebo Q2W. Keep a diary of their symptoms and the number of times they use a rescue inhaler
Read the detailed description
Eligible subjects enrolled in this study must meet the following criteria: male or female subjects aged 18-75 years with moderate to severe asthma; weighing ≥ 40 kg with a body mass index between 18-40 kg/m2; having been diagnosed with chronic asthma for at least 1 year prior to screening; receiving moderate- to high-dose inhaled corticosteroids (ICS) for at least 3 months prior to screening; used at least one other asthma control drug, such as LABA, LTRA, etc., which have been stable for at least 1 month prior to screening.
This study consists of 2 parts. Part I is a phase Ib, randomized, double-blind, placebo-controlled, parallel-group, multiple dose-escalation study which is designed to determine the safety, PK, immunogenicity, and preliminary clinical efficacy of multiple doses of HB0056 Injection in subjects with moderate or severe asthma. Part II is a phase II clinical study aimed at exploring the efficacy and safety of different dosing regimens of HB0056 for the treatment of moderate to severe asthma, and recommending the optimal treatment regimen for the phase III clinical study.
- Conditions
- Asthma
- Being tested
- Placebo, HB0056
- Keywords
- HB0056-BA-02-01, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
HB0056Drug
Targeting TSLP and IL-11 IgG1-type Bispecific Antibody
| Study group | Role | What they receive |
|---|---|---|
| HB0056 | Active comparator | HB0056 SC injection every 2/4 weeks . Receives: Drug: HB0056 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I(Phase Ib): AEs
Incidence of participants with adverse events
Measured: From baseline to week 16
Part I (Phase Ib): Tss_max
The time required to reach the maximum concentration of HB0056 in the bloodstream after administration at steady state.
Measured: From baseline to week 16
Part II (Phase II): Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Measured: From baseline to week 12
Secondary outcomes (11)
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at each evaluation time
Measured: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Change from baseline in Fractional exhaled nitric oxide(FeNO) at each evaluation time
Measured: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Change from baseline in forced vital capacity(FVC) at each evaluation time
Measured: Part II (Phase II): 52 weeks
Change from baseline in The Forced Expiratory Flow 25-75% (FEF 25-75%) at each evaluation time
Measured: Part II (Phase II): 52 weeks
Change from baseline in peak expiratory flow (PEF) at each evaluation time
Measured: Part I(Phase Ib): 16 weeks
Change from baseline in Asthma Control Questionnaire( ACQ-6) at each evaluation time
Measured: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Annualized rate of the severe asthma exacerbation event
Measured: Part II (Phase II): 52 weeks
Time to the first onset of the severe asthma exacerbation event
Measured: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) score at each evaluation time point
Measured: Part II (Phase II): 52 weeks
Incidence of Adverse events (AEs)
Measured: Part II (Phase II): 56 weeks
Incidence of anti-drug antibodies (ADAs)
Measured: Part I(Phase Ib): 16 weeksPart II (Phase II): 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start21 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899996
- Sponsor's protocol ID
- HB0056-BA-02-01
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of HB0056 in Adult Participants With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT07899996
- Acronym / sponsor ID
- HB0056-BA-02-01
- Conditions
- Asthma
- Keywords
- HB0056-BA-02-01, asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 28 Oct 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.
The goal of this clinical trial is to learn if drug HB0056 works to treat severe asthma in adults. It will also learn about the safety of drugHB0056. The main questions it aims to answer are:
Does drug HB0056 lower the number of times participants need to use a rescue inhaler? What medical problems do participants have when taking drug HB0056? Researchers will compare drug HB0056 to a placebo to see if drug HB0056 works to treat severe asthma.
Participants will:
Take drug HB0056 or a placebo Q2W. Keep a diary of their symptoms and the number of times they use a rescue inhaler
Detailed description
Eligible subjects enrolled in this study must meet the following criteria: male or female subjects aged 18-75 years with moderate to severe asthma; weighing ≥ 40 kg with a body mass index between 18-40 kg/m2; having been diagnosed with chronic asthma for at least 1 year prior to screening; receiving moderate- to high-dose inhaled corticosteroids (ICS) for at least 3 months prior to screening; used at least one other asthma control drug, such as LABA, LTRA, etc., which have been stable for at least 1 month prior to screening.
This study consists of 2 parts. Part I is a phase Ib, randomized, double-blind, placebo-controlled, parallel-group, multiple dose-escalation study which is designed to determine the safety, PK, immunogenicity, and preliminary clinical efficacy of multiple doses of HB0056 Injection in subjects with moderate or severe asthma. Part II is a phase II clinical study aimed at exploring the efficacy and safety of different dosing regimens of HB0056 for the treatment of moderate to severe asthma, and recommending the optimal treatment regimen for the phase III clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB0056 | Active comparator | Drug: HB0056HB0056 SC injection every 2/4 weeks . |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects aged 18-75 years (inclusive) [as of the date of signing the informed consent form (ICF)];
- Body weight≥ 40 KG and body mass index is between 18-40 kg/m2;
- Diagnosis of asthma with a medical history of at least 1 year;
- Those who have received a moderate-to-high dose of ICS (≥ 250 μg fluticasone propionate dry powder formulation equivalent total daily dose) for ≥ 3 consecutive months prior to screening, combined with at least one asthma control drug that has been maintained a stable treatment regimen and dose for ≥ 1 month prior to screening;
- At least 1 asthma exacerbation within 12 months prior to screening;
Key exclusion criteria (11 listed)
- Clinically significant lung diseases other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity hypoventilation syndrome, lung cancer, α1-antitrypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases other than asthma that results in peripheral blood eosinophil count increased (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
- Any disease judged as unstable by the investigator, including but not limited to unstable cardiovascular, gastrointestinal, hepatic, renal, nervous system, musculoskeletal, infectious, endocrine, metabolic, hematological, and psychiatric diseases or major physical injury.
- Subjects with current or a history of cancer (except skin squamous cell carcinoma in situ, basal cell carcinoma or cervical carcinoma in situ without any signs of recurrence for more than 5 years after complete response following radical treatment);
- History of clinically significant infection within 14 days prior to screening, which includes upper respiratory tract infection (URTI) and lower respiratory tract infection (LRTI), requiring antibiotic or antiviral treatment;
- Major surgery within 8 weeks prior to screening or planned surgery requiring general anaesthesia or hospitalization for > 1 day during the study period;
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| HB0056Targeting TSLP and IL-11 IgG1-type Bispecific Antibody | Drug | HB0056 |
Primary outcome
Part I(Phase Ib): AEs
Time frame: From baseline to week 16
Incidence of participants with adverse events
Part I (Phase Ib): Tss_max
Time frame: From baseline to week 16
The time required to reach the maximum concentration of HB0056 in the bloodstream after administration at steady state.
Part II (Phase II): Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Time frame: From baseline to week 12
11 secondary outcomes
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at each evaluation time
Time frame: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Change from baseline in Fractional exhaled nitric oxide(FeNO) at each evaluation time
Time frame: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Change from baseline in forced vital capacity(FVC) at each evaluation time
Time frame: Part II (Phase II): 52 weeks
Change from baseline in The Forced Expiratory Flow 25-75% (FEF 25-75%) at each evaluation time
Time frame: Part II (Phase II): 52 weeks
Change from baseline in peak expiratory flow (PEF) at each evaluation time
Time frame: Part I(Phase Ib): 16 weeks
Change from baseline in Asthma Control Questionnaire( ACQ-6) at each evaluation time
Time frame: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Annualized rate of the severe asthma exacerbation event
Time frame: Part II (Phase II): 52 weeks
Time to the first onset of the severe asthma exacerbation event
Time frame: Part I(Phase Ib): 16 weeksPart II (Phase II): 52 weeks
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) score at each evaluation time point
Time frame: Part II (Phase II): 52 weeks
Incidence of Adverse events (AEs)
Time frame: Part II (Phase II): 56 weeks
Incidence of anti-drug antibodies (ADAs)
Time frame: Part I(Phase Ib): 16 weeksPart II (Phase II): 56 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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HB0056 in people with Asthma, 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Oct 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jingjing Wang (86-21-5132 0051, jingjing.wang@huaota.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part I(Phase Ib): AEs (time frame: From baseline to week 16). The study lists 3 primary outcomes in all. 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 28 Oct 2026.