Healthy VolunteerPhase 1NCT06955741
A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants
A Phase 1 study testing BMS-986446 IV, BMS-986446 SC and Acetaminophen in people with Healthy Volunteer, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BMS-986446 IV, BMS-986446 SC and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2025to 11 Sep 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
- Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.
Who cannot join
- Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
- Participants must not have prior exposure to BMS-986446 (PRX005).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0001
Anaheim, California, 92801
Local Institution - 10000
Anaheim, California, 92801
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants
The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants
- Conditions
- Healthy Volunteer
- Being tested
- BMS-986446 IV, BMS-986446 SC, Acetaminophen, Loratadine
- Keywords
- Bioavailability Study, Subcutaneous Injection, Anti-MTBR Tau Monoclonal Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986446 IVDrug
Specified dose on specified days was administered intravenously (IV).
BMS-986446 SCDrug
Specified dose on specified days was administered subcutaneously (SC).
AcetaminophenDrug
Specified dose on specified days
LoratadineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: BMS-986446 IV; Drug: Acetaminophen; Drug: Loratadine |
| Arm B | Experimental | Not described Receives: Drug: BMS-986446 SC; Drug: Acetaminophen; Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
Measured: Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
Measured: Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
Measured: Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
Measured: Up to approximately Day 85
Secondary outcomes (20)
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately Day 85
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to approximately Day 85
Number of Participants With AEs Reported Related to BMS-986446
Measured: Up to approximately Day 85
Number of Participants With Clinically Significant Vital Sign Abnormalities
Measured: Up to approximately Day 85
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Measured: Up to approximately Day 85
Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities
Measured: Up to approximately Day 85
Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to approximately Day 85
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: Up to approximately Day 85
Cmax of BMS-986446
Measured: Up to approximately Day 85
AUC(0-T) of BMS-986446
Measured: Up to approximately Day 85
AUC(0-672) of BMS-986446
Measured: Up to approximately Day 85
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446
Measured: Up to approximately Day 85
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446
Measured: Up to approximately Day 85
Apparent Terminal Serum Half-life (T-HALF) of BMS-986446
Measured: Up to approximately Day 85
Total Body Clearance in IV Infusion (CLT) of BMS-986446
Measured: Up to approximately Day 85
Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446
Measured: Up to approximately Day 85
Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446
Measured: Up to approximately Day 85
Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446
Measured: Up to approximately Day 85
Number of Participants With Anti-drug Antibody Development
Measured: Up to approximately Day 85
Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire
Participant-reported response will be obtained using questionnaires that assess for pain (using a Numeric Rating Scale), itching, burning, pressure, and soreness/tenderness at the site injection.
Measured: Up to approximately Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start5 May 2025
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 46 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
- NCT06955741
- Sponsor's protocol ID
- CN008-0026
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/disclosure-commitment.htm
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants
- ClinicalTrials.gov ID
- NCT06955741
- Acronym / sponsor ID
- CN008-0026
- Conditions
- Healthy Volunteer
- Keywords
- Bioavailability Study, Subcutaneous Injection, Anti-MTBR Tau Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 2 May 2025 (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 assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BMS-986446 IV, Drug: Acetaminophen, Drug: Loratadine |
| Arm B | Experimental | Drug: BMS-986446 SC, Drug: Acetaminophen, Drug: Loratadine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
- Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.
Key exclusion criteria (3 listed)
- Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
- Participants must not have prior exposure to BMS-986446 (PRX005).
- 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-986446 IVSpecified dose on specified days was administered intravenously (IV). | Drug | Arm A |
| BMS-986446 SCSpecified dose on specified days was administered subcutaneously (SC). | Drug | Arm B |
| AcetaminophenSpecified dose on specified days | Drug | Arm A, Arm B |
| LoratadineSpecified dose on specified days | Drug | Arm A, Arm B |
Primary outcome
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC
Time frame: Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986446 Administered IV versus SC
Time frame: Up to approximately Day 85
GMR of Area Under the Serum Concentration-time Curve From Time Zero to 672 Hours (AUC(0-672)) of BMS-986446 Administered IV versus SC
Time frame: Up to approximately Day 85
Absolute Bioavailability (F) Estimated From GMR of AUC(INF) of BMS-986446 Administered as SC versus IV Infusion
Time frame: Up to approximately Day 85
20 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately Day 85
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately Day 85
Number of Participants With AEs Reported Related to BMS-986446
Time frame: Up to approximately Day 85
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Up to approximately Day 85
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time frame: Up to approximately Day 85
Number of Participants With Clinically Significant Physical Examination (PE) Abnormalities
Time frame: Up to approximately Day 85
Number of Participants With Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Day 85
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Up to approximately Day 85
Cmax of BMS-986446
Time frame: Up to approximately Day 85
AUC(0-T) of BMS-986446
Time frame: Up to approximately Day 85
AUC(0-672) of BMS-986446
Time frame: Up to approximately Day 85
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986446
Time frame: Up to approximately Day 85
Time of Maximum Observed Serum Concentration (Tmax) of BMS-986446
Time frame: Up to approximately Day 85
Apparent Terminal Serum Half-life (T-HALF) of BMS-986446
Time frame: Up to approximately Day 85
Total Body Clearance in IV Infusion (CLT) of BMS-986446
Time frame: Up to approximately Day 85
Apparent Total Body Clearance in SC Administration (CLT/F) of BMS-986446
Time frame: Up to approximately Day 85
Volume of Distribution of Terminal Phase in IV Infusion (Vz) of BMS-986446
Time frame: Up to approximately Day 85
Apparent Volume of Distribution of Terminal Phase in SC Administration (Vz/F) of BMS-986446
Time frame: Up to approximately Day 85
Number of Participants With Anti-drug Antibody Development
Time frame: Up to approximately Day 85
Local Tolerance Evaluation SC Administration of BMS-986646 Assessed by Questionnaire
Time frame: Up to approximately Day 85
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 1 Oct 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/disclosure-commitment.htm
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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
2 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 BMS-986446 IV, BMS-986446 SC and Acetaminophen in people with Healthy Volunteer, run by Bristol-Myers Squibb at 2 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 2 inclusion and 3 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Geometric Mean Ratio (GMR) of Maximum Observed Serum Concentration (Cmax) of BMS-986446 Administered IV versus SC (time frame: Up to approximately Day 85). The study lists 4 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 1 Oct 2025.