Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Teprotumumab safety check in healthy chinese participants

NCT ID NCT07142642

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study tested a single dose of teprotumumab (Tepezza) in 20 healthy Chinese adults. The goal was to see how the drug moves through the body and check for side effects. Participants received either the drug or a placebo by IV, and researchers measured drug levels and any health changes.

What this could mean

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

Active substance
teprotumumab (Tepezza)

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

20 people

The number who actually took part.

Started

Aug 2025

Finished

Jan 2026

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

18 to 60 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. Participant has provided informed consent. 2. Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry). 3. Male or female participants, between 18 and 60 years of age (inclusive). Female participants must be of nonchildbearing potential. 4. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations. 5. Body mass index between 18 and 27 kg/m\^2 (inclusive) and minimum weight of 55 kg . Exclusion Criteria: 1. History or evidence of clinically significant disorder, condition, or disease. 2. History of diabetes. (regardless of type with the exception of history of gestational diabetes). Hemoglobin A1C greater than or equal to 6.5% (greater than or equal to 48 mmol/mol). 3. Fasting glucose level (after at least an 8-hour fast) \> 126 mg/dL (\> 7 mmol/L). 4. History of or ongoing hearing impairment. 5. History of any autoimmune disease, inflammatory bowel disease, or TED. 6. History or evidence of ECG-findings. 7. Systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, or diastolic blood pressure ≥ 90 mmHg or \< 50 mmHg, or pulse \> 100 bpm or \< 50 bpm , at screening or check-in. 8. History of relevant drug and/or food allergies. 9. Poor peripheral venous access and/or unable to receive IV infusion therapy. 10. Estimated glomerular filtration rate less than 90 mL/min/1.73 m2. 11. Active liver disease or hepatic dysfunction. 12. History of a medical condition associated with an increased risk of bleeding. 13. History of any major surgery within 6 months. 14. History of alcoholism or drug/chemical abuse within 1 year prior to check-in. 15. Use of tobacco- or nicotine-containing products within 6 months prior to check-in. 16. Positive test for illicit drugs and/or tetrahydrocannabinol/cannabinoids at check-in. 17. Female participants with a positive serum pregnancy test. 18. Female participants who are lactating/breastfeeding. 19. Male participants with partners who are pregnant. 20. Unwilling to adhere to contraceptive requirements. 21. Participant has received a dose of an investigational drug within the past 90 days. 22. Have previously completed or withdrawn from this study or any other study investigating teprotumumab or have previously received the investigational product.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Graves Ophthalmopathy

As listed by the trial registrant

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

Contacts and locations

Locations

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

More trials for these conditions

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