Study Complete
Sponsor ID
20240181

A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

Sponsor ID
20240181
Clinicaltrials.gov ID
NCT07142642
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
20
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of Teprotumumab

Timeframe: Up to Day 85

Area Under the Serum Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Teprotumumab

Timeframe: Up to Day 85

Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf) of Teprotumumab

Timeframe: Up to Day 85

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events

Timeframe: Up to Day 85

Number of Participants With Serious Adverse Events

Timeframe: Up to Day 85

Number of Participants With Anti-teprotumumab Antibodies

Timeframe: Up to Day 85

Locations

Location
Status
Contact Us
Location
Huashan Hospital, Fudan University
Shanghai, Shanghai, China, 200040
Status
Recruiting