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New drug NTB003 enters first human safety tests

NCT ID NCT07182552

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 1 trial is testing a new drug called NTB003 in 40 healthy adults to see if it is safe and how the body processes it. Participants will receive either NTB003 or a placebo in increasing doses. The study is an early step toward possibly treating thyroid eye disease, but it does not yet involve patients with the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NTB003
What this could lead to
If this early safety study succeeds, it could pave the way for testing NTB003 as a treatment for thyroid eye disease.
What could go wrong
This is a very early Phase 1 trial in only 40 healthy people, not patients. It is designed to check safety, not effectiveness, so success here does not guarantee the drug will work for the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Ensure good communication with the Investigator, understand and comply with all requirements of the study, voluntarily participate in the trial, and sign the informed consent form. 2\. participants aged between 25 and 45 inclusive at the time of signing the informed consent form. 3\. Body mass index (BMI) is 19.0 kg/m2≤BMI≤26.0 kg/m2, and men must weigh ≥50 kg and women must weigh≥45 kg. 4\. Physical health and do not have any clinical diseases (including respiratory system, circulatory system, digestive system, nervous system, blood system, genitourinary system, endocrine system diseases) or mental illness (including depression, schizophrenia, etc.) during the screening interview. 5\. Physical examination, electrocardiogram, vital signs, laboratory and other related examinations are normal or abnormalities are of no clinical significance at screening. 6\. Agree to use reliable contraceptive methods with their partners during the trial; female volunteers of childbearing age must have a negative pregnancy test before the first use of the study drug. Exclusion Criteria: 1. Known or suspected allergy to the investigational drug or any of its components, or predisposition to allergy. 2. Previous treatment with any anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody. 3. Presence of scars, tattoos, moles, tenderness, bruising, erythema, induration, or damage at the intended injection site. 4. Difficulty with blood collection, inability to tolerate venous indwelling catheterization, or a history of syncope due to venipuncture. 5. Abnormal or did not have results for hepatitis B surface antigen, hepatitis C virus antibody, combined human immunodeficiency virus (HIV) antigen/antibody test, or Treponema pallidum antibody (TP-Ab). 6. History or suspected history of diabetes mellitus, or fasting blood glucose or glycated hemoglobin (HbA1c) above the upper limit of normal during screening. 7. History of ear diseases, ear surgery, hearing impairment, or a family history of hearing disorders. 8. History of thymic diseases such as thymoma or myasthenia gravis, or autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, or inflammatory bowel disease. 9. Use of any medications within 2 weeks prior to screening, including prescription drugs, over-the-counter drugs, herbal medicines, traditional Chinese medicines, and dietary supplements. 10. Any active or suspected bacterial, viral, or fungal infection within 4 weeks prior to screening, such as common cold, viral syndrome, influenza-like symptoms. 11. Receipt of live attenuated or inactivated vaccines within 4 weeks prior to screening, or planned vaccination with such vaccines during the study period. 12. Underwent surgical procedures within 3 months prior to screening, or plans to undergo surgery during the study period. 13. Participation in any other clinical trial and receipt of an investigational drug within 3 months prior to screening. 14. Blood donation or significant blood loss (\>400 mL), receipt of blood transfusion or blood products within 3 months prior to screening, or plans to donate blood or blood components during the study or within 3 months after completion. 15. Current smoker or history of smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from tobacco products during the study. 16. History of alcohol abuse or regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine); unwillingness to abstain from alcohol or alcohol-containing products during the study; or abnormal/unperformed breath alcohol test results. 17. History of drug abuse or use of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine) within 1 year prior to screening; or positive/unperformed urine drug screening results. 18. Special dietary requirements incompatible with a standardized diet. 19. Occurrence of acute illness during the screening phase or prior to study drug administration. 20. Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aerospace Center Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.