Study Complete
Sponsor ID
HZNP-TEP-102

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

Sponsor ID
HZNP-TEP-102
Clinicaltrials.gov ID
NCT06563856
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
37
Additional Study Details

Protocol Summary

Primary Outcome Measures

Cohort 1, 2, and 4: Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Percentage of the Area Extrapolated for Calculation of AUCinf (%AUCextrap) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Maximum Observed Serum Concentration (Cmax) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Last Quantifiable Serum Concentration (Clast) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Time to Maximum Observed Serum Concentration (Tmax) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Time of Last Quantifiable Serum Concentration (Tlast) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Apparent Terminal Elimination Rate Constant (λz) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Apparent Terminal Half-life (t1/2) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Apparent Serum Clearance (CL/F) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 1, 2, and 4: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Secondary Outcome Measures

Cohort 3: AUCinf of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: AUClast of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: %AUCextrap of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: Cmax of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: Clast of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: Tlast of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: λz of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: t1/2 of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: Total Serum Clearance (CL) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: Estimated Volume of Distribution at Steady State (Vss) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Cohort 3: Volume of Distribution During the Terminal Phase (Vz) of TEPEZZA

Timeframe: Day 1 pre-dose to Day 71

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to approximately Day 71

Number of Participants Experiencing Serious Adverse Events (SAEs)

Timeframe: Up to approximately Day 71

Number of Participants with Detectable Anti-drug Antibodies (ADA) to TAPEZZA

Timeframe: Day 1 pre-dose to Day 71

Locations

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