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

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Rocatinlimab vial injection; Combination Product: Rocatinlimab prefilled syringe

• Registration Number: NCT06268860
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study Start: 2024-02-15
• Study First Posted: 2024-02-20
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocatinlimab Vial	Rocatinlimab vial injection	Participants will receive rocatinlimab vial solution SC
Rocatinlimab Prefilled Syringe	Rocatinlimab prefilled syringe	Participants will receive rocatinlimab prefilled syringe solution SC

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab	Up to Day 112
Maximum Observed Serum Concentration (Cmax) of Rocatinlimab	Up to Day 112
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab	Up to Day 112

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Serious Adverse Events (SAE)	Up to approximately 20 weeks	A SAE is defined as any adverse event (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.
Number of Participants Positive to Anti-rocatinlimab Antibody	Up to Day 112
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)	Up to approximately 20 weeks	TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Trial Locations

Locations (4)

Fortrea Clinical Research Unit Inc. - Madison; 🇺🇸 Madison, Wisconsin, United States

Fortrea Clinical Research Unit - Dallas; 🇺🇸 Dallas, Texas, United States

Fortrea Clinical Research Unit Limited - Leeds; 🇬🇧 Leeds, LDS, United Kingdom

Fortrea Clinical Research Unit - Daytona Beach; 🇺🇸 Daytona Beach, Florida, United States