A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2023-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

NCT06937619

Healthy Volunteer

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

NCT06571266

Healthy Volunteers

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

NCT07007091

Healthy Volunteers

COMPLETED PHASE1

Phase 1 BA Study, Single Center With Healthy Volunteers

NCT00870948

Healthy

COMPLETED PHASE1

MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)

NCT06649877

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abatacept Treatment A

Group Type EXPERIMENTAL

Abatacept

Intervention Type BIOLOGICAL

Specified dose on specified days

Abatacept Treatment B

Group Type EXPERIMENTAL

Abatacept

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abatacept

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Orencia® BMS-188667

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy participants, defined as having no clinically significant deviation from normal in medical history; physical examinations that would compromise the ability to participate, complete, and/or interpret the results of the study; 12-lead ECG; vital signs; and clinical laboratory results
* Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening
* Participant must have a suitable injection site without tattoos, scarring, or other conditions in the upper, outer arm that could interfere with SC administration

Exclusion Criteria

* Present malignancy or previous malignancy within the last 5 years prior to screening
* At risk for tuberculosis
* Any chronic bacterial infection within the previous 12 weeks of dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes