NCT07413536

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
9mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

January 30, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 30, 2026

Last Update Submit

February 9, 2026

Conditions

Health Adult Subjects

Outcome Measures

Primary Outcomes (1)

  • AEs

    including Adverse events defined by CTCAE 5.0(Common Terminology Criteria for Adverse Events version 5.0)

    From ICF signed to day 113 after investigational drug administration

Secondary Outcomes (8)

  • t1/2

    From day 1 to day 113

  • Cmax

    From day 1 to day 113

  • Tmax

    From day 1 to day 113

  • AUC 0-t

    From day 1 to day 113

  • AUC0-∞

    From day 1 to day 113

  • +3 more secondary outcomes

Study Arms (10)

EB070 treatment group-21mg cohort

EXPERIMENTAL

EB070 injection, 21mg，single dose

Biological: EB070

Placebo group-21mg cohort

PLACEBO COMPARATOR

Placebo injection, 21mg，single dose

Biological: EB070

EB070 treatment group-75mg cohort

EXPERIMENTAL

EB070 injection, 75mg，single dose

Biological: EB070

Placebo group-75mg cohort

PLACEBO COMPARATOR

Placebo injection, 75mg，single dose

Biological: EB070

EB070 treatment group-225mg cohort

EXPERIMENTAL

EB070 injection, 225mg，single dose

Biological: EB070

Placebo group-225mg cohort

PLACEBO COMPARATOR

Placebo injection, 225mg，single dose

Biological: EB070

EB070 treatment group-450mg cohort

EXPERIMENTAL

EB070 injection, 450mg，single dose

Biological: EB070

Placebo group-450mg cohort

PLACEBO COMPARATOR

Placebo injection, 450mg，single dose

Biological: EB070

EB070 treatment group-600mg cohort

EXPERIMENTAL

EB070 injection, 600mg，single dose

Biological: EB070

Placebo group-600mg cohort

PLACEBO COMPARATOR

Placebo injection, 600mg，single dose

Biological: EB070

Interventions

EB070BIOLOGICAL

Anti-TSLP Monoclonal Antibody

EB070 treatment group-21mg cohortEB070 treatment group-225mg cohortEB070 treatment group-450mg cohortEB070 treatment group-600mg cohortEB070 treatment group-75mg cohortPlacebo group-21mg cohortPlacebo group-225mg cohortPlacebo group-450mg cohortPlacebo group-600mg cohortPlacebo group-75mg cohort

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 to 60 years old.
  • Sex: Healthy male and female participants.
  • Body weight: ≥50 kg for males and ≥45 kg for females; body mass index (BMI = weight \[kg\] / height \[m²\]) between 18 and 26 kg/m².
  • Participants of reproductive potential (both male and female) must agree to use reliable contraception (hormonal, barrier method, or abstinence) during the study and for at least 3 months after study completion. Female participants of childbearing potential must have a negative pregnancy test (β-HCG) at screening and baseline and must not be breastfeeding.
  • Informed consent: Participants must have been adequately informed about the study, voluntarily sign the informed consent form, and be willing and able to comply with study procedures.

You may not qualify if:

  • Abnormal findings at screening in physical examination, vital signs, 12-lead ECG, or laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation function, and thyroid function) deemed clinically significant by the investigator.
  • Positive serology for any of the following: hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antigen/antibody.
  • History of any clinically significant disease affecting the respiratory, digestive, cardiovascular, hematologic/lymphatic, nervous, psychiatric, genitourinary, endocrine, hepatic, renal, dermatologic, or metabolic systems, or any other condition that could interfere with study results.
  • Blood pressure at screening: systolic ≥140 mmHg or \<90 mmHg, or diastolic ≥90 mmHg or \<50 mmHg.
  • Planned major surgery during the study, or major surgery within 1 month prior to randomization.
  • History of chronic infection, particularly bacterial, viral, fungal, or parasitic infection within 1 month prior to randomization.
  • Known allergy to EB070 or any excipients, history of hypersensitivity to antibody-based biologics, or history of specific allergic conditions (e.g., allergic conjunctivitis, allergic asthma, atopic dermatitis), or any clinically significant food, drug, insect bite, foreign protein, or monoclonal antibody allergy as judged by the investigator.
  • Alcohol abuse: ≥28 standard drinks per week within 1 year prior to randomization, or frequent drinking (\>14 standard drinks/week) within 6 months prior to randomization; or failed breath alcohol test (\>0 mg/100 mL) at screening or Day 1. (One standard drink contains 14 g alcohol, e.g., 360 mL beer, 45 mL 40% liquor, or 150 mL wine.)
  • Smoking ≥5 cigarettes per day or equivalent tobacco use (e.g., nicotine gum/lozenges) within 3 months prior to randomization, inability to abstain during the study, or positive urine cotinine test at screening or Day 1.
  • Participation in any clinical trial of an investigational drug within 3 months prior to randomization (or within 5 half-lives, whichever is longer).
  • Use of any medications or dietary supplements (prescription, over-the-counter, herbal, or traditional Chinese medicine) within 14 days prior to randomization, or within 5 half-lives of the study drug.
  • Use of any biologic products within 3 months prior to randomization (or within 5 half-lives, whichever is longer).
  • Administration of live or attenuated vaccines within 1 month prior to randomization or planned during the study.
  • History of substance abuse (e.g., morphine, cannabis, methamphetamine, MDMA, ketamine) within 1 year prior to randomization, or positive urine drug screen at screening or Day 1.
  • Blood donation or significant blood loss (≥400 mL) within 3 months prior to randomization, or planned donation during the study or within 3 months after study completion.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-01