Study Complete
Sponsor ID
20220015
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
Study Details
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
Protocol Summary
Primary Outcome Measures
Maximum Observed Serum Concentration (Cmax) of Rocatinlimab
Timeframe: Up to Day 112
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Timeframe: Up to Day 112
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Timeframe: Up to Day 112
Secondary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Timeframe: Up to approximately 20 weeks
Number of Participants Experiencing Serious Adverse Events (SAE)
Timeframe: Up to approximately 20 weeks
Number of Participants Positive to Anti-rocatinlimab Antibody
Timeframe: Up to Day 112
Locations
Location
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, FL, United States, 32117-5116
Status
Recruiting
Location
Fortrea Clinical Research Unit - Dallas
Dallas, TX, United States, 75247-4903
Status
Recruiting
Location
Fortrea Clinical Research Unit Limited - Leeds
Leeds, LDS, United Kingdom, LS2 9LH
Status
Recruiting
Location
Fortrea Clinical Research Unit Inc. - Madison
Madison, WI, United States, 53704-2526
Status
Recruiting