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.
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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