AsthmaPhase 1NCT07886710
A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study of Multiple Ascending Doses of EB070 Injection in Adults With Moderate-to-Severe Asthma
A Phase 1 study testing EB070 in people with Asthma, run by Biotech Pharmaceutical Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- EB070
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 28 Dec 2028
- Phase
- Phase 1
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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:
- 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;
- 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.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of EB070 Injection in Adult Patients With Moderate-to-Severe Asthma
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.
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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
- Being tested
- EB070
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB070Biological
Anti-TSLP Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| EB070 injection, 225mg，multiple dose | Experimental | Not described Receives: Biological: EB070 |
| Placebo injection, 225mg，multiple dose | Placebo comparator | Not described Receives: Biological: EB070 |
| EB070 injection, 600mg，multiple dose | Experimental | Not described Receives: Biological: EB070 |
| Placebo injection, 600mg，multiple dose | Placebo comparator | Not described Receives: Biological: EB070 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
including Adverse events defined by CTCAE 6.0(Common Terminology Criteria for Adverse Events version 6.0)
Measured: From the Start of Dosing Through Week 32
Secondary outcomes (22)
Tss_max
The time required to reach the maximum concentration of EB070 in the bloodstream after administration at steady state.
Measured: From Week 1 to Week 32
Css_max
The maximum concentration of EB070 in the bloodstream during a dosing interval at steady state.
Measured: From Week 1 to Week 32
Css_min
The minimum concentration of EB070 in the bloodstream during a dosing interval at steady state.
Measured: From Week 1 to Week 32
AUCss 0-t
The area under the concentration-time curve of EB070 from the start to the last measurable concentration during a dosing interval at steady state.
Measured: From week 1 to week 32
AUCss 0-∞
The area under the concentration-time curve of EB070 from the start of a dosing interval to infinity at steady state.
Measured: From week 1 to week 32
RAUC
The ratio of EB070 exposure after repeated dosing to that after a single dose.
Measured: From week 1 to week 32
RCmax
The ratio of the maximum EB070 concentration after repeated dosing to that after a single dose.
Measured: From week 1 to week 32
CL/Fss
The apparent clearance of EB070 from the bloodstream at steady state.
Measured: From week 1 to week 32
Vz/Fss
The apparent volume of distribution of EB070 at steady state.
Measured: From week 1 to week 32
Kelss
The elimination rate constant of EB070 at steady state.
Measured: From week 1 to week 32
t½ss
The time required for the concentration of EB070 in the bloodstream to decrease by 50% at steady state.
Measured: From week 1 to week 32
MRT
The mean residence time of EB070 in the body.
Measured: From week 1 to week 32
CLR
The renal clearance of EB070.
Measured: From week 1 to week 32
FeNO
Measured: Baseline; Weeks 5, 9, 13, 17, and 21
Eosinophil Count
Measured: Baseline; Weeks 5, 9, 13, 17, and 21
IL5 Concentration
Measured: Baseline; Weeks 5, 9, 13, 17, and 21
IL-13 Concentration
Measured: Baseline; Weeks 5, 9, 13, 17, and 21
IgE Concentration
Measured: Baseline; Weeks 5, 9, 13, 17, and 21
Change from baseline in pre-bronchodilator (Pre-BD) forced expiratory volume in 1 second (FEV1) measured before dosing at each assessment time point
Measured: Weeks 5, 9, 13, 17, and 21
Change from baseline in peak expiratory flow (PEF) at each assessment time point
Measured: Weeks 5, 9, 13, 17, and 21
Change from baseline in Asthma Control Test (ACT) score at each assessment time point
Measured: Weeks 5, 9, 13, 17, and 21
Number of participants experiencing asthma exacerbations and number of asthma exacerbation episodes at each assessment time point
Measured: Weeks 5, 9, 13, 17, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion28 Dec 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.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886710
- Sponsor's protocol ID
- BPL-EB070-Asthma-1002
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No