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

Sponsor ID
HZNP-TEP-104
Clinicaltrials.gov ID
NCT06674941
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
44
Additional Study Details

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
Status
Contact Us
Location
PPD Development, LP
Las Vegas, Nevada, United States, 89113-2237
Status
Completed