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

NCT05981976 | Completed Phase 1 FDA Drug

• 1 other identifier: IM101-920
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy Participants

Keywords

Abatacept; Orencia; Pharmacokinetics; Bioavailability; BMS-188667

Outcome Measures

Primary Outcomes (3)

• Maximum observed serum concentration (Cmax)

  Up to Day 71

• Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))

  Up to Day 71

• Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))

  Up to Day 71

Secondary Outcomes (9)

• Number of participants with adverse events (AEs)

  Up to Month 12

• Number of participants with clinical laboratory abnormalities

  Up to Month 12

• Number of participants with vital sign abnormalities

  Up to Month 12

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 71

• Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))

  Up to Day 71

Study Arms (2)

Abatacept Treatment A

EXPERIMENTAL

Biological: Abatacept

Abatacept Treatment B

EXPERIMENTAL

Biological: Abatacept

Interventions

Abatacept BIOLOGICAL

Specified dose on specified days

Also known as: Orencia®, BMS-188667

Abatacept Treatment A; Abatacept Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution

Cypress, California, 90630, United States

Location

Local Institution

Miami, Florida, 33147, United States

Location

Local Institution

Las Vegas, Nevada, 89113, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: August 18, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)