Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
Lead Sponsor:
Amgen
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Participant has provided informed consent.
- Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
- Male or female participants, between 18 and 60 years of age (inclusive). Female participants must be of nonchildbearing potential.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Body mass index between 18 and 27 kg/m\^2 (inclusive) and minimum weight of 55 kg .
Exclusion
- History or evidence of clinically significant disorder, condition, or disease.
- 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).
- Fasting glucose level (after at least an 8-hour fast) \> 126 mg/dL (\> 7 mmol/L).
- History of or ongoing hearing impairment.
- History of any autoimmune disease, inflammatory bowel disease, or TED.
- History or evidence of ECG-findings.
- 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.
- History of relevant drug and/or food allergies.
- Poor peripheral venous access and/or unable to receive IV infusion therapy.
- Estimated glomerular filtration rate less than 90 mL/min/1.73 m2.
- Active liver disease or hepatic dysfunction.
- History of a medical condition associated with an increased risk of bleeding.
- History of any major surgery within 6 months.
- History of alcoholism or drug/chemical abuse within 1 year prior to check-in.
- Use of tobacco- or nicotine-containing products within 6 months prior to check-in.
- Positive test for illicit drugs and/or tetrahydrocannabinol/cannabinoids at check-in.
- Female participants with a positive serum pregnancy test.
- Female participants who are lactating/breastfeeding.
- Male participants with partners who are pregnant.
- Unwilling to adhere to contraceptive requirements.
- Participant has received a dose of an investigational drug within the past 90 days.
- Have previously completed or withdrawn from this study or any other study investigating teprotumumab or have previously received the investigational product.
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07142642
Start Date
August 26 2025
End Date
December 15 2025
Last Update
December 19 2025
Active Locations (1)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040