MedTrace Logo

A Phase Ia Single Ascending-Dose Study of Subcutaneous EB070 Injection in Healthy Volunteers

NCT07413536 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Health Adult Subjects

Interventions

BIOLOGICAL

EB070

Anti-TSLP Monoclonal Antibody

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-12-31
Completion
2027-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07413536 on ClinicalTrials.gov