Study Complete
Sponsor ID
20240181
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
Study Details
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.
Protocol Summary
Primary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
Timeframe: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab
Timeframe: Up to Day 85
Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab
Timeframe: Up to Day 85
Secondary Outcome Measures
Number of Participants With Treatment-emergent Adverse Events
Timeframe: Up to Day 85
Number of Participants With Serious Adverse Events
Timeframe: Up to Day 85
Number of Participants With Anti-teprotumumab Antibodies
Timeframe: Up to Day 85
Locations
Location
Huashan Hospital, Fudan University
Shanghai, Shanghai, China, 200040
Status
Recruiting