Teprotumumab safety check in healthy chinese participants
NCT ID NCT07142642
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 Hide 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.
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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.
Contacts and locations
Locations
-
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
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