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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
37
PPD Development
Las Vegas, Nevada, United States
Cohort 1, 2, and 4: Area Under the Serum Concentration-time Curve (AUC) From Time 0 Extrapolated to Infinity (AUCinf) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Percentage of the Area Extrapolated for Calculation of AUCinf (%AUCextrap) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Maximum Observed Serum Concentration (Cmax) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Last Quantifiable Serum Concentration (Clast) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Time to Maximum Observed Serum Concentration (Tmax) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Time of Last Quantifiable Serum Concentration (Tlast) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Apparent Terminal Elimination Rate Constant (λz) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Apparent Terminal Half-life (t1/2) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 1, 2, and 4: Apparent Serum Clearance (CL/F) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
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Cohort 1, 2, and 4: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: AUCinf of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: AUClast of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: %AUCextrap of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: Cmax of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: Clast of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: Tlast of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: λz of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: t1/2 of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: Total Serum Clearance (CL) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: Estimated Volume of Distribution at Steady State (Vss) of TEPEZZA
Time frame: Day 1 pre-dose to Day 71
Cohort 3: Volume of Distribution During the Terminal Phase (Vz) of TEPEZZA
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately Day 71
Number of Participants with Detectable Anti-drug Antibodies (ADA) to TAPEZZA
Time frame: Day 1 pre-dose to Day 71