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Monoclonal Antibodies

Rocatinlimab Vial for Atopic Dermatitis

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
Healthy male or female participants, between 18 and 65 years of age (inclusive)
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old and in good health.

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,458 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,901 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
~153 spots leftby Aug 2024