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TEPEZZA

Phase 1

Bioavailability | Small molecule | Other |Amgen Inc.|Last Updated: Aug 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06563856A Study of TEPEZZA Subcutaneous Administration in Healthy AdultsPHASE1 COMPLETED 37 — — Sep 22, 2020May 27, 2021Aug 21, 20241 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1: TEPEZZA Dose A SubQEXPERIMENTALParticipants will receive Dose A of TEPEZZA administered SubQ.
Cohort 2: TEPEZZA Dose B SubQEXPERIMENTALParticipants will receive Dose B of TEPEZZA administered SubQ.
Cohort 3: TEPEZZA Dose B Intravenously (IV)EXPERIMENTALParticipants will receive Dose B of TEPEZZA administered IV.
Cohort 4: TEPEZZA Dose B and EDP SubQEXPERIMENTALParticipants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ.
Interventions
NameTypeDescription
TEPEZZADRUGAdministered as a SubQ injection or IV injection.
EDPDRUGAdministered as a SubQ injection.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The participant is able to provide written informed consent. * The participant is male or female 18 to 55 years of age, inclusive. * The participant has a body mass index (BMI) between 21 to 30 kg/m\^², inclusive, and a minimum weight of 55 kg at Screening. * The participant i...

Countries:United States
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