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Monoclonal Antibodies

Rocatinlimab Vial for Atopic Dermatitis

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 112
Awards & highlights

Study Summary

This trial aims to compare how the body processes a drug called rocatinlimab when it is given as a single injection using a vial versus a prefilled syringe in healthy volunteers.

Who is the study for?
This trial is for healthy men and women aged 18 to 65 with a body mass index (BMI) between 18 and 32. Participants must give informed consent before any study-specific activities begin.Check my eligibility
What is being tested?
The trial is testing the bioavailability of Rocatinlimab, which means how well it gets into the bloodstream when given as an injection from a vial versus from a prefilled syringe in healthy people.See study design
What are the potential side effects?
As this trial involves healthy participants, detailed side effects are not provided, but common side effects may include reactions at the injection site, such as pain or swelling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 112
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 112 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
Maximum Observed Serum Concentration (Cmax) of Rocatinlimab
Secondary outcome measures
Number of Participants Experiencing Serious Adverse Events (SAE)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Number of Participants Positive to Anti-rocatinlimab Antibody

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rocatinlimab VialExperimental Treatment1 Intervention
Participants will receive rocatinlimab vial solution SC
Group II: Rocatinlimab Prefilled SyringeExperimental Treatment1 Intervention
Participants will receive rocatinlimab prefilled syringe solution SC

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,383 Previous Clinical Trials
1,379,681 Total Patients Enrolled
MDStudy DirectorAmgen
929 Previous Clinical Trials
926,728 Total Patients Enrolled
~80 spots leftby Aug 2024
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