Study Complete
Sponsor ID
HZNP-TEP-104
A trial to investigate teprotumumab (high-concentration formulation) subcutaneous administration in healthy adult non-Japanese and Japanese participants
Study Details
The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and to assess the PK of teprotumumab delivered by syringe pump and by an injection device in non-Japanese participants.
Protocol Summary
Primary Outcome Measures
Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
Maximum Observed Serum Concentration (Cmax) of Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
Time to Cmax (Tmax) of Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
Secondary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to Day 57
Number of Participants with Anti-drug Antibodies (ADA) to Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
Titer of Positive ADA to Teprotumumab
Timeframe: Day 1 pre-dose to Day 57
Locations
Location
PPD Development, LP
Las Vegas, Nevada, United States, 89113-2237
Status
Completed