Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Healthy Chinese participants, Thyroid eye disease, TED, Thyroid-associated ophthalmopathy
Brief summary
The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.
Interventions
DRUGTeprotumumab
Administered via IV infusion.
DRUGPlacebo
Administered via IV infusion.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Serum Concentration (Cmax) of Teprotumumab | Up to Day 85 |
| Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab | Up to Day 85 |
| Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab | Up to Day 85 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Up to Day 85 |
| Number of Participants With Serious Adverse Events | Up to Day 85 |
| Number of Participants With Anti-teprotumumab Antibodies | Up to Day 85 |
Countries
China
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed