Healthy ParticipantsPhase 1NCT04736134
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
A Phase 1 study testing BMS-986326 and Multiple Ascending Dose SC in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986326 and Multiple Ascending Dose SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- 3 Mar 2021to 14 Mar 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health, as determined by the investigator based on a physical examination at screening
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening
- Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
- Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
- Must agree to follow specific methods of contraception, if applicable
Who cannot join
- Women who are pregnant or lactating
- History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
- History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.
- Conditions
- Healthy Participants
- Being tested
- BMS-986326, Placebo matching BMS-986326, Multiple Ascending Dose SC, Multiple Ascending Dose Placebo
- Keywords
- BMS-986326, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986326Biological
Specified dose on specified days
Placebo matching BMS-986326Other
Specified dose on specified days
Multiple Ascending Dose SCBiological
Specified dose on specified days
Multiple Ascending Dose PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment (BMS 986326) IV | Experimental | Intravenous (IV) Receives: Biological: BMS-986326 |
| Active Treatment (BMS 986326) SC | Experimental | Subcutaneous (SC) Receives: Biological: BMS-986326 |
| Placebo IV | Placebo comparator | Not described Receives: Other: Placebo matching BMS-986326 |
| Placebo SC | Placebo comparator | Not described Receives: Other: Placebo matching BMS-986326 |
| Multiple Ascending Dose Placebo SC | Placebo comparator | Placebo Receives: Other: Multiple Ascending Dose Placebo |
| Multiple Ascending Dose SC | Experimental | BMS 986326 SC Receives: Biological: Multiple Ascending Dose SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 175 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 175 days
Number of participants with vital sign abnormalities
Measured: Up to 175 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 175 days
Number of participants with physical examinations abnormalities
Measured: Up to 175 days
Secondary outcomes (7)
Maximum observed serum concentration (Cmax)
Measured: Up to 175 days
Time of maximum observed serum concentration (Tmax)
Measured: Up to 175 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Measured: Up to 175 days
Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)]
Measured: Up to 175 days
Change in regulatory T cells (Treg) count
Measured: Up to 175 days
Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio
Measured: Up to 175 days
Number of participants with anti-drug antibodies
Measured: Up to 175 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start3 Mar 2021
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 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
- NCT04736134
- Sponsor's protocol ID
- IM034-001
- Other IDs
- 2020-002763-64, U1111-1252-7566
- Status last verified
- Apr 2024
- First submitted
- 29 Jan 2021
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04736134
- Acronym / sponsor ID
- IM034-001
- Conditions
- Healthy Participants
- Keywords
- BMS-986326, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 3 Feb 2021 (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 evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active Treatment (BMS 986326) IV | Experimental | Biological: BMS-986326Intravenous (IV) |
| Active Treatment (BMS 986326) SC | Experimental | Biological: BMS-986326Subcutaneous (SC) |
| Placebo IV | Placebo comparator | Other: Placebo matching BMS-986326 |
| Placebo SC | Placebo comparator | Other: Placebo matching BMS-986326 |
| Multiple Ascending Dose Placebo SC | Placebo comparator | Other: Multiple Ascending Dose PlaceboPlacebo |
| Multiple Ascending Dose SC | Experimental | Biological: Multiple Ascending Dose SCBMS 986326 SC |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In good health, as determined by the investigator based on a physical examination at screening
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening
- Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
- Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
- Must agree to follow specific methods of contraception, if applicable
Key exclusion criteria (5 listed)
- Women who are pregnant or lactating
- History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
- History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products
- 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 |
|---|---|---|
| BMS-986326Specified dose on specified days | Biological | Active Treatment (BMS 986326) IV, Active Treatment (BMS 986326) SC |
| Placebo matching BMS-986326Specified dose on specified days | Other | Placebo IV, Placebo SC |
| Multiple Ascending Dose SCSpecified dose on specified days | Biological | Multiple Ascending Dose SC |
| Multiple Ascending Dose PlaceboSpecified dose on specified days | Other | Multiple Ascending Dose Placebo SC |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 175 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 175 days
Number of participants with vital sign abnormalities
Time frame: Up to 175 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 175 days
Number of participants with physical examinations abnormalities
Time frame: Up to 175 days
7 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Up to 175 days
Time of maximum observed serum concentration (Tmax)
Time frame: Up to 175 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to 175 days
Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)]
Time frame: Up to 175 days
Change in regulatory T cells (Treg) count
Time frame: Up to 175 days
Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio
Time frame: Up to 175 days
Number of participants with anti-drug antibodies
Time frame: Up to 175 days
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 6 May 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986326 and Multiple Ascending Dose SC in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in Germany.
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 5 inclusion and 5 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Number of participants with adverse events (AEs) (time frame: Up to 175 days). The study lists 5 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 6 May 2024.