A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study of Multiple Ascending Doses of EB070 Injection in Adults With Moderate-to-Severe Asthma

Any concomitant respiratory disease that, in the investigator's opinion, may interfere with the assessment of the safety or pharmacodynamic effects of the study drug or the interpretation of study results, including, but not limited to, active pulmonary infection, other active pulmonary lesions, or pulmonary space-occupying lesions indicated by chest X-ray (pulmonary imaging obtained within 3 months prior to screening is acceptable), chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity-related hypoventilation syndrome, alpha-1 antitrypsin deficiency, and primary ciliary dyskinesia; or any pulmonary or systemic disease other than asthma associated with elevated peripheral blood eosinophil counts, such as allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, or hypereosinophilic syndrome.

A confirmed diagnosis of occupational asthma.

Current smoker or a smoking history of ≥10 pack-years (pack-years = number of cigarettes smoked per day / 20 × number of years smoked). Former smokers with a smoking history of \<10 pack-years must have discontinued smoking for at least 6 months before enrollment.

An asthma exacerbation occurring within 8 weeks prior to screening through the first dose that required systemic corticosteroid treatment for ≥3 days or resulted in an emergency department visit or hospitalization for ≥24 hours.

An upper respiratory tract infection occurring within 4 weeks prior to screening through the first dose; or a pulmonary or other infection requiring intravenous antibiotics, antifungal agents, or antiviral agents.

A diagnosis of helminthic parasitic infection within 6 months prior to screening that has not been treated or has failed to respond to standard treatment.

Use of another investigational drug within 5 half-lives or 30 days prior to screening, whichever is longer, or before the pharmacodynamic effect of the investigational drug has returned to baseline, whichever is longer; or a longer washout period if required for the investigational drug.

Use of short-acting muscarinic antagonists (SAMA), such as ipratropium bromide, within 2 weeks prior to screening.

Use of traditional Chinese medicines with antiasthmatic effects within 2 weeks prior to screening.

Use of pranlukast within 4 weeks prior to screening.

Receipt of a biologic agent with the same therapeutic purpose within 4 months or 5 half-lives prior to randomization, whichever is longer, including anti-thymic stromal lymphopoietin (TSLP) monoclonal antibodies, anti-IL-4Rα monoclonal antibodies, anti-IL-5/IL-5R monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics with the same therapeutic purpose.

Receipt of allergen-specific immunotherapy within 3 months prior to randomization.

A history of bronchial thermoplasty.

Use of systemic immunosuppressive/immunomodulatory agents or biologic agents for the treatment of other autoimmune or inflammatory diseases within 8 weeks or 5 half-lives prior to randomization, whichever is longer, or ongoing treatment with such agents.

Receipt of immunoglobulins or other blood products within 3 months prior to screening.

Laboratory abnormalities meeting any of the following criteria:

1. Hematology: hemoglobin \<90 g/L, white blood cell (WBC) count \<3.0 × 10⁹/L, platelet count \<100 × 10⁹/L, or absolute neutrophil count (ANC) \<1.5 × 10⁹/L;

2. Blood chemistry: total bilirubin \>1.5 × ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × ULN, or serum creatinine \>1.5 × ULN.

Any disease or medical condition that, in the investigator's judgment, is not clinically stable, including, but not limited to, unstable cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, or psychiatric diseases, or major physical injuries.

A history of organ, hematopoietic stem cell, or bone marrow transplantation.

Receipt of a live or live-attenuated vaccine within 30 days prior to screening, or plans to receive a live or live-attenuated vaccine during the study.

A history of malignancy in any organ system within the past 5 years, except for adequately treated localized basal cell carcinoma of the skin or carcinoma in situ of the cervix, regardless of whether there is evidence of local recurrence or metastasis.

A history of immediate hypersensitivity reactions following previous treatment with any biologic agent, or a documented diagnosis of immune complex disease (Type III hypersensitivity reaction).

Positive human immunodeficiency virus (HIV) antibody; positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with positive HBV DNA; positive hepatitis C virus (HCV) antibody; or positive syphilis antibody test.

A history of tuberculosis, or a positive interferon-gamma release assay (IGRA) at screening. An IGRA result obtained within 3 months prior to screening is acceptable.

A history of chronic alcohol abuse or drug abuse within 12 months prior to randomization.

Known hypersensitivity to EB070 or any of its excipients, including histidine, histidine hydrochloride, sorbitol, or polysorbate 80.

Known history of poor adherence to medication or study procedures, inability or unwillingness to complete the study questionnaires, or inability to perform pulmonary function tests correctly.

Pregnancy, breastfeeding, plans to become pregnant, or unwillingness to use reliable contraception during the study and for 3 months after the last dose in women of childbearing potential or sexually active men. Participants who donate sperm during the same period are also excluded.

Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study, including major surgery, significant medical conditions, psychiatric disorders, or other relevant conditions.

What this study is about