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Recruiting Phase 1/2

A Study of HB0056 in Adult Participants With Moderate to Severe Asthma

NCT07899996 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-08-21
Last updated
2026-10-28

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

PlaceboHB0056 →

Placebo: Placebo

HB0056: Targeting TSLP and IL-11 IgG1-type Bispecific Antibody

Study 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female subjects aged 18-75 years (inclusive) \[as of the date of signing the informed consent form (ICF)\]; 2. Body weight≥ 40 KG and body mass index is between 18-40 kg/m2; 3. Diagnosis of asthma with a medical history of at least 1 year; 4. 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; 5. At least 1 asthma exacerbation within 12 months prior to screening; 6. 40% ≤ FEV1 \< 80% of predicted normal value pre-bronchodilator at screening; 7. 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; 8. ACQ-6 score ≥1.5 prior to randomization; 9. No birth planning and voluntarily use effective contraception throughout the study until 6 months after the last dose; Exclusion Criteria: 1. 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). 2. 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. 3. 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); 4. 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; 5. Major surgery within 8 weeks prior to screening or planned surgery requiring general anaesthesia or hospitalization for \> 1 day during the study period; 6. Helminth parasite infection diagnosed within 6 months prior to screening, not receiving or responding to standard of care; 7. 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); 8. Subjects with a history of alcoholism or drug abuse or dependence. 9. Those with active tuberculosis infection or latent tuberculosis requiring treatment at screening; 10. Those who are allergic or intolerant to components of HB0056 injection or placebo or have a history of severe drug allergy or anaphylactic shock; 11. Subjects who are considered inappropriate to participate in this clinical trial by the investigator.

Primary outcome measure(s)

  • Part I(Phase Ib): AEs — From baseline to week 16
    Incidence of participants with adverse events
  • Part I (Phase Ib): Tss_max — 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) — From baseline to week 12

Trial sites (2)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing China Recruiting
China-Japan Friendship Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07899996 on ClinicalTrials.gov ↗ ← All trials in China