NCT06674941

A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants

A Phase 1, Open-label, Single-dose Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial are to assess the pharmacokinetics (PK) of a single subcutaneous (SC) administration of teprotumumab high-concentration formula (HCF) in healthy adult non-Japanese and Japanese participants and to assess the PK of teprotumumab delivered by syringe pump and by an injection device in non-Japanese participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Teprotumumab	Administered as an SC injection.

Timeline

• Start date: 2023-03-24
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2024-11-05
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study