A Study of TEPEZZA Subcutaneous Administration in Healthy Adults
NCT Number: NCT06563856
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bioavailability|Bioequivalence
Interventions: DRUG: TEPEZZA|DRUG: EDP
Sponsor: Amgen
Sex: ALL
Age: ADULT
Enrollment: 37
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-09-22
Completion Date: 2021-05-27
Locations: PPD Development, Las Vegas, Nevada, 89113, United States

Summary:
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.

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, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Percentage of the Area Extrapolated for Calculation of AUCinf (%AUCextrap) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Maximum Observed Serum Concentration (Cmax) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Last Quantifiable Serum Concentration (Clast) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Time to Maximum Observed Serum Concentration (Tmax) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Time of Last Quantifiable Serum Concentration (Tlast) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Apparent Terminal Elimination Rate Constant (λz) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Apparent Terminal Half-life (t1/2) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Apparent Serum Clearance (CL/F) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 1, 2, and 4: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of TEPEZZA, Day 1 pre-dose to Day 71
Secondary Outcome Measures: Cohort 3: AUCinf of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: AUClast of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: %AUCextrap of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: Cmax of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: Clast of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: Tlast of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: λz of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: t1/2 of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: Total Serum Clearance (CL) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: Estimated Volume of Distribution at Steady State (Vss) of TEPEZZA, Day 1 pre-dose to Day 71|Cohort 3: Volume of Distribution During the Terminal Phase (Vz) of TEPEZZA, Day 1 pre-dose to Day 71|Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Participants will be instructed to contact the investigator at any time after receiving the study drug, if any symptoms develop. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure., Up to approximately Day 71|Number of Participants Experiencing Serious Adverse Events (SAEs), An AE is considered an SAE if, in the view of either the investigator or sponsor, it results in any of the following outcomes:

* Death
* Life-threatening AE
* Inpatient hospitalization or prolongation of existing hospitalization
* Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
* Congenital anomaly or birth defect., Up to approximately Day 71|Number of Participants with Detectable Anti-drug Antibodies (ADA) to TAPEZZA, Day 1 pre-dose to Day 71