Rocatinlimab
DrugVial supplied as a single-use preservative free solution for SC injection.
Other names: AMG 451
NCT Number: NCT06438263
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Fortrea Clinical Research Unit - Daytona Beach, Daytona Beach, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inactive vaccination (e.g., non-live or nonreplicating agent), including coronavirus-2019 (COVID-19) vaccination, is allowed.
Vial supplied as a single-use preservative free solution for SC injection.
Other names: AMG 451
Time frame: Up to approximately 112 days
Time frame: Up to approximately 112 days
Time frame: Up to approximately 112 days
Time frame: Approximately 20 weeks
TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs.
A serious AE (SAE) is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to approximately Day 112
Amgen
Industry
An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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