A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study of Multiple Ascending Doses of EB070 Injection in Adults 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. 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