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Monoclonal Antibodies

Rocatinlimab Vial for Atopic Dermatitis

Q: What are the eligibility criteria for individuals interested in participating in this research project?

<p>For this clinical trial on <a href="https://www.withpower.com/clinical-trials/atopic-dermatitis">atopic dermatitis</a>, 230 eligible individuals aged between 18 to 65 are being sought. Essential requirements include obtaining informed consent before engaging in any study-related tasks, having a body mass index falling within the range of 18 to 32 kg/m^2, and being generally healthy males or females within the specified age bracket.</p>

Phase 1

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 112

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,377,988 Total Patients Enrolled

MDStudy DirectorAmgen

915 Previous Clinical Trials

924,500 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 80 and above eligible to participate in this study?

"To be eligible for this research trial, participants must be at least 18 years old but no older than 65."

Answered by AI

At how many sites is this particular research study currently being conducted?

"Fortrea Leeds Clinical Research Unit in Yorkshire, Fortrea Daytona Beach Clinical Research Unit in Florida, and Fortrea Madison Clinical Research Unit in Wisconsin are among the sites open for patient enrollment. Additionally, four other locations are also participating in this trial."

Answered by AI

What is the total number of subjects being examined in this particular research investigation?

"For this research endeavor, a total of 230 eligible participants are sought for enrollment. Individuals meeting the defined criteria can choose to engage in this medical investigation at varied locations including Fortrea Leeds Clinical Research Unit located in Leeds, Yorkshire and Fortrea Daytona Beach Clinical Research Unit situated in Daytona Beach, Florida."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"For this clinical trial on atopic dermatitis, 230 eligible individuals aged between 18 to 65 are being sought. Essential requirements include obtaining informed consent before engaging in any study-related tasks, having a body mass index falling within the range of 18 to 32 kg/m^2, and being generally healthy males or females within the specified age bracket."

Answered by AI

What is the risk level associated with Rocatinlimab Vial in individuals?

"With insufficient data supporting its safety and efficacy, Rocatinlimab Vial was assigned a rating of 1 by our team at Power due to the early Phase 1 trial stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268860.

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