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AzTrials

Health Adult SubjectsPhase 1NCT07413536

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

A Phase 1 study testing EB070 in people with Health Adult Subjects, run by Biotech Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Health Adult Subjects
What is being tested?
EB070
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
No sites listed yet
Study dates
Mar 2026to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • History of syncope or needle phobia, or inability to tolerate blood draws.
  • Positive interferon-gamma release assay (T-SPOT.TB). Subjects without tuberculosis history or symptoms may be included if results are within twice the upper limit of normal.
  • Any other condition that the investigator judges makes the participant unsuitable for the study.

About this study

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

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:

Read more

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.

Being tested
EB070

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EB070Biological

    Anti-TSLP Monoclonal Antibody

Study groups in NCT07413536
Study groupRoleWhat they receive
EB070 treatment group-21mg cohortExperimentalEB070 injection, 21mg，single dose
Receives: Biological: EB070
Placebo group-21mg cohortPlacebo comparatorPlacebo injection, 21mg，single dose
Receives: Biological: EB070
EB070 treatment group-75mg cohortExperimentalEB070 injection, 75mg，single dose
Receives: Biological: EB070
Placebo group-75mg cohortPlacebo comparatorPlacebo injection, 75mg，single dose
Receives: Biological: EB070
EB070 treatment group-225mg cohortExperimentalEB070 injection, 225mg，single dose
Receives: Biological: EB070
Placebo group-225mg cohortPlacebo comparatorPlacebo injection, 225mg，single dose
Receives: Biological: EB070
EB070 treatment group-450mg cohortExperimentalEB070 injection, 450mg，single dose
Receives: Biological: EB070
Placebo group-450mg cohortPlacebo comparatorPlacebo injection, 450mg，single dose
Receives: Biological: EB070
EB070 treatment group-600mg cohortExperimentalEB070 injection, 600mg，single dose
Receives: Biological: EB070
Placebo group-600mg cohortPlacebo comparatorPlacebo injection, 600mg，single dose
Receives: Biological: EB070

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs

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

    Measured: From ICF signed to day 113 after investigational drug administration

Secondary outcomes (8)

  1. t1/2

    is the time required for the concentration of EB070 in the bloodstream to decrease by exactly 50%. It is a measure of how quickly the body eliminates EB070.

    Measured: From day 1 to day 113

  2. Cmax

    is the highest concentration of EB070 measured in the blood plasma after a dose is administered.

    Measured: From day 1 to day 113

  3. Tmax

    is the time elapsed from drug administration until the maximum plasma concentration (Cₘₐₓ) is reached.It is a measure of the rate of drug absorption.

    Measured: From day 1 to day 113

  4. AUC 0-t

    It is calculated by plotting plasma concentration against time and measuring the total area under that curve up to the last sampled time point.

    Measured: From day 1 to day 113

  5. AUC0-∞

    Area Under the Plasma Concentration-Time Curve from time zero extrapolated to infinity. It is calculated as AUC₀-ₜ + (Cₜ / λz), where Cₜ is the last measurable concentration and λz is the terminal elimination rate constant.

    Measured: From day 1 to day 113

  6. Vz

    is a theoretical volume that relates the total amount of drug in the body to its plasma concentration during the terminal elimination phase.

    Measured: From day 1 to day 113

  7. CL

    Clearance is the volume of plasma (or blood) from which EB070 is completely removed per unit of time

    Measured: From day 1 to day 113

  8. ADA

    Anti-Drug Antibodies are immune proteins (antibodies) produced by a patient's immune system that specifically bind to EB070，using sensitive immunoassays (like ECL/ELISA) often combined with acid-dissociation techniques to overcome drug interference and accurately quantify the immune response.

    Measured: From day 1 to day 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07413536
Sponsor's protocol ID
BPL-EB070-HV-1001
Status last verified
Jan 2026
First submitted
30 Jan 2026
Last updated
17 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EB070 in people with Health Adult Subjects, run by Biotech Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs (time frame: From ICF signed to day 113 after investigational drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07413536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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