Study Complete
Sponsor ID
20220014

A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants

Sponsor ID
20220014
Clinicaltrials.gov ID
NCT06438263
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
Rocatinlimab
Type
Interventional
Masking
None (Open Label)
Enrollment
231
Additional Study Details

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
Status
Contact Us
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