NCT06563856

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TEPEZZA Subcutaneous Administration in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability
• Bioequivalence

Interventions

Type	Name	Description
DRUG	TEPEZZA	Administered as a SubQ injection or IV injection.
DRUG	EDP	Administered as a SubQ injection.

Timeline

• Start date: 2020-09-22
• Primary completion: 2021-05-27
• Completion: 2021-05-27
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study