A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administ… (NCT07142642) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
China20 participantsStarted 2025-08-26
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
Timeframe: Up to Day 85
2
Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab
Timeframe: Up to Day 85
3
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab