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A Phase Ia Single Ascending-Dose Study of Subcutaneous EB070 Injection in Healthy Volunteers
Sponsor: Biotech Pharmaceutical Co., Ltd.
Summary
The goal of this Phase Ia clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of EB070 injection following single ascending subcutaneous doses in healthy adult volunteers. The main questions it aims to answer are: Is EB070 injection safe and well tolerated at increasing single subcutaneous dose levels in healthy subjects? What are the pharmacokinetic characteristics of EB070 after single-dose administration? This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose (SAD) study. A total of 36 healthy volunteers will be enrolled and assigned to one of five dose cohorts (21 mg, 75 mg, 225 mg, 450 mg, or 600 mg). Subjects in each cohort will be randomized in a 3:1 ratio to receive a single subcutaneous injection of EB070 or placebo. A sentinel dosing strategy will be applied. In the 21 mg cohort, one subject will initially receive EB070. In the remaining cohorts, two sentinel subjects (one receiving EB070 and one receiving placebo) will be dosed first. Dose escalation and enrollment of the remaining subjects will proceed after evaluation of safety and tolerability within 48 hours after dosing. Participants will: Undergo screening assessments prior to dosing Receive a single subcutaneous injection of EB070 or placebo Stay in the Phase I unit for approximately 3 days for safety monitoring and pharmacokinetic and anti-drug antibody (ADA) sample collection Return for scheduled outpatient visits for PK, ADA, and safety assessments through Day 113 Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, 12-lead ECGs, and laboratory tests. Pharmacokinetic parameters and anti-drug antibodies (ADA) will be evaluated as secondary outcomes.
Official title: A Phase Ia Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous EB070 Injection in Healthy Volunteers
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-03
Completion Date
2027-03
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
EB070
Anti-TSLP Monoclonal Antibody