Study Complete
Sponsor ID
20220014
A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
Study Details
The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.
Protocol Summary
Primary Outcome Measures
Maximum Plasma Concentration (Cmax) of Rocatinlimab
Timeframe: Up to approximately 112 days
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Timeframe: Up to approximately 112 days
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Timeframe: Up to approximately 112 days
Secondary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Approximately 20 weeks
Number of Participants with Anti-rocatinlimab Antibodies
Timeframe: Up to approximately Day 112
Locations
Location
Fortrea Clinical Research Unit Inc. - Madison
Madison, WI, United States, 53704-2526
Status
Recruiting
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, 75247-4968
Status
Recruiting