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NOT YET RECRUITING
NCT07886710
PHASE1

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

Sponsor: Biotech Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-30

Completion Date

2028-12-28

Last Updated

2026-10-21

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

EB070

Anti-TSLP Monoclonal Antibody