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

NCT07886710 | Not Yet Recruiting Phase 1

• 1 other identifier: BPL-EB070-Asthma-1002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation Phase Ib clinical study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, immunogenicity, and clinical efficacy of EB070 Injection in adult patients with moderate-to-severe asthma. The study will also explore the optimal dose for achieving biological effects and the recommended dose for Phase II development. Based on the results of the Phase I study in healthy participants, two ascending dose groups are planned: 225 mg and 600 mg, administered sequentially across study centers. The doses are provisional and may be adjusted based on the results of the Phase I study in healthy participants and the emerging results of this study. Each dose group is planned to enroll 10 participants, who will be randomized in a 4:1 ratio to receive EB070 Injection or placebo by subcutaneous injection into the abdomen once every 4 weeks for a total of 4 doses. Approximately 20 adult patients with moderate-to-severe asthma are expected to be enrolled. Each participant may participate in only one dose group. Dose escalation will proceed only after the Safety Review Committee (SRC), consisting of an independent unblinded third-party physician, the investigator, and the sponsor, confirms that all participants in the preceding dose group have demonstrated acceptable safety and tolerability within 2 weeks after the second dose. If predefined dose-escalation termination criteria are met, the SRC will review the safety data and may consider returning to an intermediate dose between the affected dose and the preceding dose to further explore the maximum tolerated dose. If the highest dose specified in the protocol is reached without meeting the dose termination criteria, the SRC will determine whether escalation to a higher dose is appropriate. If a participant discontinues for reasons unrelated to safety, the SRC will determine whether additional participants should be enrolled in the affected dose group. If any serious adverse event (SAE) related to the investigational drug occurs, or if ≥2 participants in a dose group experience similar Grade 3 adverse events related to the investigational drug, enrollment into the relevant dose group will be suspended. The SRC will conduct a comprehensive assessment of the event, including its severity, relationship to the investigational drug, time to onset, clinical manifestations, reversibility, and other available safety data. Enrollment may resume only after the SRC confirms that the risk is controllable and approves continuation of the study. Potentially eligible participants will undergo screening assessments within 21 days before the first dose to determine eligibility. Eligible participants will undergo baseline assessments within 1 day before dosing (Day -1). For assessments such as physical examination, complete blood count, urinalysis, and blood chemistry, results obtained within 7 days before dosing may be used as baseline values. Participants confirmed by the investigator to meet all inclusion criteria and none of the exclusion criteria will undergo baseline PK and PD sample collection within 1 hour before the first dose. Participants will subsequently receive four subcutaneous doses of EB070 Injection or placebo at 4-week intervals. During the study, participants will attend scheduled visits for study drug administration and collection of PK, PD, and immunogenicity samples, as well as assessments of safety, tolerability, and clinical efficacy according to the protocol-defined schedule.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• AEs

  including Adverse events defined by CTCAE 6.0(Common Terminology Criteria for Adverse Events version 6.0)

  From the Start of Dosing Through Week 32

Secondary Outcomes (22)

• Tss_max

  From Week 1 to Week 32

• Css_max

  From Week 1 to Week 32

• Css_min

  From Week 1 to Week 32

• AUCss 0-t

  From week 1 to week 32

• AUCss 0-∞

  From week 1 to week 32

Study Arms (4)

EB070 injection, 225mg，multiple dose

EXPERIMENTAL

Biological: EB070

Placebo injection, 225mg，multiple dose

PLACEBO COMPARATOR

Biological: EB070

EB070 injection, 600mg，multiple dose

EXPERIMENTAL

Biological: EB070

Placebo injection, 600mg，multiple dose

PLACEBO COMPARATOR

Biological: EB070

Interventions

EB070 BIOLOGICAL

Anti-TSLP Monoclonal Antibody

EB070 injection, 225mg，multiple dose; EB070 injection, 600mg，multiple dose; Placebo injection, 225mg，multiple dose; Placebo injection, 600mg，multiple dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate-to-severe asthma who meet the diagnostic criteria specified in the 2024 Guidelines for the Prevention and Treatment of Bronchial Asthma, with a history of asthma for at least 1 year. Moderate asthma is defined as asthma that can be well controlled with Step 3 treatment, while severe asthma is defined as asthma that requires Step 4 or Step 5 treatment to achieve good control, or remains uncontrolled despite 3 months of treatment at Step 4 or Step 5.
• Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form.
• A documented bronchodilator reversibility test conducted during screening or within at least 12 months prior to screening demonstrating an increase in forced expiratory volume in 1 second (FEV1) of ≥12% and an absolute increase of ≥200 mL.
• Pre-bronchodilator FEV1 ≥40% and \<80% of the predicted value at screening.
• Asthma Control Test (ACT) score ≤19 prior to randomization.
• Treatment with a physician-prescribed medium- or high-dose inhaled corticosteroid (ICS) for at least 6 months prior to screening, with a stable ICS dose for at least 3 months prior to randomization.
• Concomitant treatment with at least one other asthma controller medication, such as a long-acting β2-agonist (LABA), long-acting muscarinic antagonist (LAMA), or leukotriene receptor antagonist (LTRA), with a stable dose for at least 3 months prior to randomization.
• Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours prior to the first dose. Postmenopausal women who have been amenorrheic for at least 12 months are considered not to be of childbearing potential. Women with a documented history of hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation are also considered not to be of childbearing potential and are not required to undergo pregnancy testing.
• Participants who understand and are willing to comply with the study procedures, voluntarily participate in the study, and provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 28, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-09