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Cohort 1: TEPEZZA Dose A SubQ for Bioavailability

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 pre-dose to day 71
Awards & highlights

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.

Eligible Conditions
  • Bioavailability
  • Bioequivalence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-dose to day 71
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-dose to day 71 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohort 1, 2, and 4: AUC From Time 0 to the Last Quantifiable Concentration (AUClast) of TEPEZZA
Cohort 1, 2, and 4: Apparent Serum Clearance (CL/F) of TEPEZZA
Cohort 1, 2, and 4: Apparent Terminal Elimination Rate Constant (λz) of TEPEZZA
+8 more
Secondary study objectives
Cohort 3: %AUCextrap of TEPEZZA
Cohort 3: AUCinf of TEPEZZA
Cohort 3: AUClast of TEPEZZA
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: TEPEZZA Dose B and EDP SubQExperimental Treatment2 Interventions
Participants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ.
Group II: Cohort 3: TEPEZZA Dose B Intravenously (IV)Experimental Treatment1 Intervention
Participants will receive Dose B of TEPEZZA administered IV.
Group III: Cohort 2: TEPEZZA Dose B SubQExperimental Treatment1 Intervention
Participants will receive Dose B of TEPEZZA administered SubQ.
Group IV: Cohort 1: TEPEZZA Dose A SubQExperimental Treatment1 Intervention
Participants will receive Dose A of TEPEZZA administered SubQ.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP
2016
Completed Phase 1
~80
TEPEZZA
2021
Completed Phase 4
~100

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,418 Previous Clinical Trials
1,382,835 Total Patients Enrolled
MDStudy DirectorAmgen
959 Previous Clinical Trials
928,750 Total Patients Enrolled
~8 spots leftby Sep 2025
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