Asthma (Diagnosis)Phase 1NCT07732023
A Randomized, Phase Ib, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SKB575 (HBM7575) in Participants With Asthma
A Phase 1 study testing SKB575 in people with Asthma (Diagnosis), run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- SKB575
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- 25 Aug 2026to 30 Jul 2028
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is able to understand and comply with the requirements of this study, and voluntarily signs the informed consent form.
- Aged between 18 and 70 years inclusive at the time of signing the informed consent form, with no restriction on gender.
- Body Mass Index (BMI) shall be ≥ 18.0 kg/m² and ≤ 32.0 kg/m².
- Diagnosis of asthma consistent with the Global Initiative for Asthma (GINA) 2025 diagnostic criteria.
- Pulmonary function test during the screening period must meet either of the following criteria: After albuterol inhalation, the forced expiratory volume in one second (FEV₁) increases by ≥ 12% with an absolute FEV₁ increment of ≥ 200 mL; or the participant has a positive result from a bronchodilator reversibility test or bronchial provocation test within the past 12 months.
- Participants must have received a stable dose of controller medication for a minimum of 3 months prior to randomization. Subjects shall be on maintenance therapy with low-, medium- or high-dose inhaled corticosteroids (ICS), which may be combined with other asthma controller medications including long-acting beta₂ agonists (LABA), long-acting muscarinic antagonists (LAMA), and leukotriene receptor antagonists (LTRA). The treatment regimen and dosage shall remain unchanged throughout the study period.
- Pre-bronchodilator forced expiratory volume in one second (FEV₁) ≥ 50% of predicted value during screening.
- Male and female participants must agree to use highly effective contraceptive methods for the specified duration of the study.
Who cannot join
- Within 3 months prior to randomization, the participant experienced an acute asthma exacerbation requiring continuous systemic corticosteroid therapy for ≥3 consecutive days, or presented to the emergency department or was hospitalized due to asthma with administration of systemic corticosteroids (calculated from the completion date of treatment for the asthma exacerbation).
- Known hypersensitivity to the investigational product or its excipients, or a history of allergic reactions to any biological products.
- Concomitant clinically significant pulmonary diseases, including but not limited to pulmonary infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, pulmonary vascular disease, pulmonary neoplasm, or any other diseases affecting pulmonary function other than asthma.
- Concomitant diseases that may impair pulmonary function, including but not limited to clinically significant pleural disorders, mediastinal diseases, diaphragmatic lesions, myasthenia, thoracic deformities, etc.
- Concomitant autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, primary biliary cholangitis, etc.
- Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis and aspergillosis), even if the infection has resolved.
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- Confirmed parasitic infection within 6 months prior to randomization; upper or lower respiratory tract infection occurring within 6 weeks prior to randomization; other active infections requiring systemic treatment identified within 1 month prior to randomization.
- Previous history of malignant neoplasm, regardless of whether treatment was administered, or whether there is evidence of local recurrence or metastasis.
- Presence of any history of severe clinically significant diseases involving cardiovascular and cerebrovascular systems, hematological system, liver, kidney, digestive tract, nervous system, respiratory system, psychiatric disorders, metabolic abnormalities, or any other diseases or physiological conditions that may interfere with the trial results.
- Participants who have undergone or are planning to undergo major surgery within 3 months prior to randomization.
- Current smoker at screening, or having quit tobacco (including e-cigarettes) for less than 6 months.
- History of drug or alcohol abuse within 2 years prior to randomization.
- Female participants who are pregnant or breastfeeding.
- Any condition deemed by the investigator to interfere with the evaluation of the investigational product, compromise participant safety, or confound the interpretation of study results.
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
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Weimin Li, MD, 86-028-85423998, weimin003@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Zhu Luo, MD, 86+18980606557, luozhu720@163.com
About this study
This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.
- Conditions
- Asthma (Diagnosis)
- Being tested
- SKB575, Placebo
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB575Drug
Subcutaneous
PlaceboDrug
Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SKB575 | Experimental | Not described Receives: Drug: SKB575 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with adverse events (AEs), serious adverse events (SAE)
Measured: From baseline to week 32
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at week 8
Measured: Week 8
Secondary outcomes (7)
Change from baseline in FeNO
Measured: From baseline to week 32
Change from baseline in pre-bronchodilator (BD) FEV1
Measured: From baseline to week 32
Change from baseline in post-BD FEV1
Measured: From baseline to week 32
Change from baseline in ACQ-5 score
ACQ-5 is Asthma control questionnaire assessing symptoms, has a scoring range of 0 to 6 points. Lower score shows better asthma control.
Measured: From baseline to week 32
Pharmacodynamic(PD): Changes from baseline in blood eosinophil count (EOS), etc.
Measured: From baseline to week 32
Pharmacokinetics (PK): Serum concentration of SKB575
Measured: From baseline to week 32
Anti-drug antibodies (ADA) against SKB575
Measured: From baseline to week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start25 Aug 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732023
- Sponsor's protocol ID
- SKB575-I-02
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase Ib, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SKB575 (HBM7575) in Participants With Asthma
- ClinicalTrials.gov ID
- NCT07732023
- Acronym / sponsor ID
- SKB575-I-02
- Conditions
- Asthma (Diagnosis)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 28 Jul 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 study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKB575 | Experimental | Drug: SKB575 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant is able to understand and comply with the requirements of this study, and voluntarily signs the informed consent form.
- Aged between 18 and 70 years inclusive at the time of signing the informed consent form, with no restriction on gender.
- Body Mass Index (BMI) shall be ≥ 18.0 kg/m² and ≤ 32.0 kg/m².
- Diagnosis of asthma consistent with the Global Initiative for Asthma (GINA) 2025 diagnostic criteria.
- Pulmonary function test during the screening period must meet either of the following criteria: After albuterol inhalation, the forced expiratory volume in one second (FEV₁) increases by ≥ 12% with an absolute FEV₁ increment of ≥ 200 mL; or the participant has a positive result from a bronchodilator reversibility test or bronchial provocation test within the past 12 months.
Key exclusion criteria (14 listed)
- Within 3 months prior to randomization, the participant experienced an acute asthma exacerbation requiring continuous systemic corticosteroid therapy for ≥3 consecutive days, or presented to the emergency department or was hospitalized due to asthma with administration of systemic corticosteroids (calculated from the completion date of treatment for the asthma exacerbation).
- Known hypersensitivity to the investigational product or its excipients, or a history of allergic reactions to any biological products.
- Concomitant clinically significant pulmonary diseases, including but not limited to pulmonary infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, pulmonary vascular disease, pulmonary neoplasm, or any other diseases affecting pulmonary function other than asthma.
- Concomitant diseases that may impair pulmonary function, including but not limited to clinically significant pleural disorders, mediastinal diseases, diaphragmatic lesions, myasthenia, thoracic deformities, etc.
- Concomitant autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, primary biliary cholangitis, etc.
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 |
|---|---|---|
| SKB575Subcutaneous | Drug | SKB575 |
| PlaceboSubcutaneous | Drug | Placebo |
Primary outcome
Incidence of participants with adverse events (AEs), serious adverse events (SAE)
Time frame: From baseline to week 32
Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at week 8
Time frame: Week 8
7 secondary outcomes
Change from baseline in FeNO
Time frame: From baseline to week 32
Change from baseline in pre-bronchodilator (BD) FEV1
Time frame: From baseline to week 32
Change from baseline in post-BD FEV1
Time frame: From baseline to week 32
Change from baseline in ACQ-5 score
Time frame: From baseline to week 32
Pharmacodynamic(PD): Changes from baseline in blood eosinophil count (EOS), etc.
Time frame: From baseline to week 32
Pharmacokinetics (PK): Serum concentration of SKB575
Time frame: From baseline to week 32
Anti-drug antibodies (ADA) against SKB575
Time frame: From baseline to week 32
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 10 Sep 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 study testing SKB575 in people with Asthma (Diagnosis), run by Sichuan Kelun-Biotech 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 8 inclusion and 14 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 10 Sep 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 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.
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 Xin Li, PhD (86-028-67255165, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of participants with adverse events (AEs), serious adverse events (SAE) (time frame: From baseline to week 32). The study lists 2 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 10 Sep 2026.