Healthy ParticipantsPhase 1NCT05981976
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
A Phase 1 study testing Abatacept in people with Healthy Participants, run by Bristol-Myers Squibb at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Abatacept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Aug 2023to 14 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution
Cypress, California, 90630
Local Institution
Las Vegas, Nevada, 89113
Local Institution
Miami, Florida, 33147
About this study
Official title: A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants
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
- Being tested
- Abatacept
- Keywords
- Abatacept, Orencia, Pharmacokinetics, Bioavailability, BMS-188667
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptBiological
Also called Orencia®, BMS-188667
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Abatacept Treatment A | Experimental | Not described Receives: Biological: Abatacept |
| Abatacept Treatment B | Experimental | Not described Receives: Biological: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax)
Measured: Up to Day 71
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
Measured: Up to Day 71
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
Measured: Up to Day 71
Secondary outcomes (9)
Number of participants with adverse events (AEs)
Measured: Up to Month 12
Number of participants with clinical laboratory abnormalities
Measured: Up to Month 12
Number of participants with vital sign abnormalities
Measured: Up to Month 12
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 71
Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
Measured: Up to Day 71
Serum concentration at 168 hours after dosing (C168)
Measured: Up to Day 71
Time of maximum observed serum concentration (Tmax)
Measured: Up to Day 71
Number of laboratory-reported positive responses of anti-abatacept antibodies
Measured: Up to Month 12
Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
Measured: Up to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start18 Aug 2023
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981976
- Sponsor's protocol ID
- IM101-920
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants
- ClinicalTrials.gov ID
- NCT05981976
- Acronym / sponsor ID
- IM101-920
- Conditions
- Healthy Participants
- Keywords
- Abatacept, Orencia, Pharmacokinetics, Bioavailability, BMS-188667
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept Treatment A | Experimental | Biological: Abatacept |
| Abatacept Treatment B | Experimental | Biological: Abatacept |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia®, BMS-188667Specified dose on specified days | Biological | Abatacept Treatment A, Abatacept Treatment B |
Primary outcome
Maximum observed serum concentration (Cmax)
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
Time frame: Up to Day 71
9 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to Month 12
Number of participants with clinical laboratory abnormalities
Time frame: Up to Month 12
Number of participants with vital sign abnormalities
Time frame: Up to Month 12
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 71
Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))
Time frame: Up to Day 71
Serum concentration at 168 hours after dosing (C168)
Time frame: Up to Day 71
Time of maximum observed serum concentration (Tmax)
Time frame: Up to Day 71
Number of laboratory-reported positive responses of anti-abatacept antibodies
Time frame: Up to Month 12
Number of laboratory-reported positive responses of anti-CTLA4-T antibodies
Time frame: Up to Day 71
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept in people with Healthy Participants, run by Bristol-Myers Squibb at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed serum concentration (Cmax) (time frame: Up to Day 71). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.