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Abatacept Processes in Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12
Awards & highlights

Study Summary

This trial tests how well a drug is absorbed into the body when applied as a shot, using two different methods.

Who is the study for?
This trial is for healthy individuals with no significant medical issues, normal physical exams, ECGs, vital signs, and lab results. They must weigh between 60-100 kg and have a clear upper arm area suitable for subcutaneous injections without tattoos or scarring.Check my eligibility
What is being tested?
The study aims to compare how the body absorbs abatacept when it's made using two different manufacturing processes. Participants will receive the drug under their skin (subcutaneously) to see if there's any difference in absorption.See study design
What are the potential side effects?
Since this trial involves healthy participants and focuses on drug levels rather than treatment effects, specific side effects are not detailed here but may include reactions at the injection site such as pain or swelling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
Maximum observed serum concentration (Cmax)
Secondary outcome measures
Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
Number of laboratory-reported positive responses of anti-abatacept antibodies
+6 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Abatacept Treatment BExperimental Treatment1 Intervention
Group II: Abatacept Treatment AExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,340 Total Patients Enrolled

Media Library

Abatacept Treatment A Clinical Trial Eligibility Overview. Trial Name: NCT05981976 — Phase 1
Healthy Subjects Research Study Groups: Abatacept Treatment A, Abatacept Treatment B
Healthy Subjects Clinical Trial 2023: Abatacept Treatment A Highlights & Side Effects. Trial Name: NCT05981976 — Phase 1
Abatacept Treatment A 2023 Treatment Timeline for Medical Study. Trial Name: NCT05981976 — Phase 1

Frequently Asked Questions

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

Has Abatacept Treatment been granted regulatory approval by the FDA?

"Our internal evaluation gave Abatacept Treatment A a score of one because it is in Phase 1, meaning that the safety and efficacy are still being established."

Answered by AI

Are individuals over the age of eighty-five being sought out for participation in this trial?

"The prerequisites for inclusion in this study are that the applicants must be between 18-55 years old. For those under 18, there are 53 other trials available and 381 studies aimed at individuals over 65."

Answered by AI

What criteria must individuals fulfill to qualify for participation in this clinical trial?

"In order to qualify for this medical trial, participants must be of sound health and between 18-55 years old. A total of 174 individuals need to be enrolled in the study."

Answered by AI

Are there any unfilled positions for this clinical trial?

"According to clinicaltrials.gov, this particular trial is not currently enrolling participants. This medical study was initially posted on August 15th of 2023 and has been updated as recent at August 1st of the same year. Despite being inactive in recruitment for patients, there are still 799 other studies actively seeking candidates right now."

Answered by AI

Who else is applying?

What site did they apply to?
Local Institution
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

It wouldn't let me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
2023. "A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05981976.
~104 spots leftby Apr 2025
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