Study Complete
Sponsor ID
20220015

A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants

Sponsor ID
20220015
Clinicaltrials.gov ID
NCT06268860
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
Rocatinlimab
Type
Interventional
Masking
None (Open Label)
Enrollment
240
Additional Study Details

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
Status
Contact Us
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