Alzheimer's DiseasePhase 1NCT07780383
A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration
A Phase 1 study testing BMS-986446 in people with Alzheimer's Disease and Healthy Participants, run by Bristol-Myers Squibb at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy Participants
- What is being tested?
- BMS-986446
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Aug 2026to 17 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must have a BMI of 18.0 to 35.0 kg/m2.
- For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.
- For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.
- For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).
- For Part C: Participants must have evidence of positive plasma pTau217.
Who cannot join
- For Parts A and B: Participants must not have a general history of any 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.
- For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.
- For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.
- For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, 92801
Amina Haggag, Site 0001, 714-774-7777
- Not yet recruiting
Local Institution - 0003
Bradenton, Florida, 34205
Site 0003
- Not yet recruiting
Local Institution - 0005
Daytona Beach, Florida, 32117
Site 0005
- Not yet recruiting
Local Institution - 0004
Decatur, Georgia, 30030
Site 0004
- Not yet recruiting
Local Institution - 0007
Naples, Florida, 34105
Site 0007
- Not yet recruiting
Local Institution - 0006
The Villages, Florida, 32162
Site 0006
About this study
Official title: A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.
The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration
- Conditions
- Alzheimer's Disease, Healthy Participants
- Being tested
- BMS-986446
- Keywords
- Healthy Participants, Early Alzheimer's Disease, BMS-986446, Subcutaneous Administration, IV administration
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986446Drug
Also called PRX005, Moponetug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Panel A1: BMS986446 | Experimental | Not described Receives: Drug: BMS-986446 |
| Panel A2: BMS986446 | Experimental | Not described Receives: Drug: BMS-986446 |
| Panel A3: BMS986446 | Experimental | Not described Receives: Drug: BMS-986446 |
| Panel B1: BMS986446 | Experimental | Not described Receives: Drug: BMS-986446 |
| Panel B2: BMS986446 | Experimental | Not described Receives: Drug: BMS-986446 |
| Panel C1: BMS986446 | Experimental | Not described Receives: Drug: BMS-986446 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion
Measured: Up to approximately 5 months
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
Measured: Up to approximately 5 months
Maximum observed concentration (Cmax)
Measured: Up to approximately 5 months
Time of maximum observed concentration (Tmax)
Measured: Up to approximately 5 months
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to approximately 5 months
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
Measured: Up to approximately 5 months
AUC(INF)
Measured: Up to approximately 5 months
Half-life (T-HALF)
Measured: Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
Measured: Up to approximately 5 months
Total body clearance in IV infusion (CLT)
Measured: Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Measured: Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
Measured: Up to approximately 5 months
Secondary outcomes (20)
Adverse events (AEs)
Measured: Up to approximately 5 months
Serious adverse events (SAEs)
Measured: Up to approximately 5 months
AEs reported as related to BMS-986446
Measured: Up to approximately 5 months
Incidence of anti-drug antibody (ADA)
Measured: Up to approximately 5 months
Local tolerance evaluation
This evaluation will assess pain, itching, burning, pressure, and soreness/tenderness (using a Numeric Rating Scale) at the injection site location.
Measured: Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for Cmax
Measured: Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
Measured: Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for Cmax
Measured: Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for AUC
Measured: Up to approximately 5 months
Cmax
Panel B1, Panel B2, Panel C1
Measured: Up to approximately 5 months
Tmax
Panel B1, Panel B2, Panel C1
Measured: Up to approximately 5 months
AUC(0-T)
Panel B1, Panel B2
Measured: Up to approximately 5 months
AUC(0-672)
Panel B1, Panel B2
Measured: Up to approximately 5 months
AUC(INF)
Panel B1, Panel B2
Measured: Up to approximately 5 months
T-HALF
Panel B1, Panel B2, Panel C1
Measured: Up to approximately 5 months
CLT/F
Panel B1, Panel B2, Panel C1
Measured: Up to approximately 5 months
Vz/F
Panel B1, Panel B2, Panel C1
Measured: Up to approximately 5 months
Trough observed plasma concentration (Ctrough)
Panel C1
Measured: Up to approximately 5 months
Concentration at the end of a dosing interval (Ctau)
Panel C1
Measured: Up to approximately 5 months
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Panel C1
Measured: Up to approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start21 Aug 2026
- Primary completion17 Jun 2027 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
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
- NCT07780383
- Sponsor's protocol ID
- CN008-0028
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Sep 2026
- 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-part Study to Evaluate Pharmacokinetics, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 Following Intravenous and Subcutaneous Administrations in Healthy Adults and Multiple Doses of BMS-986446 in Participants With Early Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT07780383
- Acronym / sponsor ID
- CN008-0028
- Conditions
- Alzheimer's Disease, Healthy Participants
- Keywords
- Healthy Participants, Early Alzheimer's Disease, BMS-986446, Subcutaneous Administration, IV administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 17 Jun 2027 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 21 Aug 2026 (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 drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Panel A1: BMS986446 | Experimental | Drug: BMS-986446 |
| Panel A2: BMS986446 | Experimental | Drug: BMS-986446 |
| Panel A3: BMS986446 | Experimental | Drug: BMS-986446 |
| Panel B1: BMS986446 | Experimental | Drug: BMS-986446 |
| Panel B2: BMS986446 | Experimental | Drug: BMS-986446 |
| Panel C1: BMS986446 | Experimental | Drug: BMS-986446 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have a BMI of 18.0 to 35.0 kg/m2.
- For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.
- For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.
- For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).
- For Part C: Participants must have evidence of positive plasma pTau217.
Key exclusion criteria (5 listed)
- For Parts A and B: Participants must not have a general history of any 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.
- For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.
- For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.
- For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).
- 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-986446Also: PRX005, MoponetugSpecified dose on specified days | Drug | Panel A1: BMS986446, Panel A2: BMS986446, Panel A3: BMS986446, Panel B1: BMS986446, Panel B2: BMS986446, Panel C1: BMS986446 |
Primary outcome
Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion
Time frame: Up to approximately 5 months
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
Time frame: Up to approximately 5 months
Maximum observed concentration (Cmax)
Time frame: Up to approximately 5 months
Time of maximum observed concentration (Tmax)
Time frame: Up to approximately 5 months
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to approximately 5 months
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
Time frame: Up to approximately 5 months
AUC(INF)
Time frame: Up to approximately 5 months
Half-life (T-HALF)
Time frame: Up to approximately 5 months
Apparent total body clearance in SC administration (CLT/F)
Time frame: Up to approximately 5 months
Total body clearance in IV infusion (CLT)
Time frame: Up to approximately 5 months
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Time frame: Up to approximately 5 months
Volume of distribution of terminal phase (VZ)
Time frame: Up to approximately 5 months
20 secondary outcomes
Adverse events (AEs)
Time frame: Up to approximately 5 months
Serious adverse events (SAEs)
Time frame: Up to approximately 5 months
AEs reported as related to BMS-986446
Time frame: Up to approximately 5 months
Incidence of anti-drug antibody (ADA)
Time frame: Up to approximately 5 months
Local tolerance evaluation
Time frame: Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for Cmax
Time frame: Up to approximately 5 months
GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
Time frame: Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for Cmax
Time frame: Up to approximately 5 months
GMR of Panel B2 vs Panel A3 for AUC
Time frame: Up to approximately 5 months
Cmax
Time frame: Up to approximately 5 months
Tmax
Time frame: Up to approximately 5 months
AUC(0-T)
Time frame: Up to approximately 5 months
AUC(0-672)
Time frame: Up to approximately 5 months
AUC(INF)
Time frame: Up to approximately 5 months
T-HALF
Time frame: Up to approximately 5 months
CLT/F
Time frame: Up to approximately 5 months
Vz/F
Time frame: Up to approximately 5 months
Trough observed plasma concentration (Ctrough)
Time frame: Up to approximately 5 months
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to approximately 5 months
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Up to approximately 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
6 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 in people with Alzheimer's Disease and Healthy Participants, run by Bristol-Myers Squibb at 6 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 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute bioavailability estimated from geometric mean ratio (GMR) of area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986446 after subcutaneous (SC) infusion (time frame: Up to approximately 5 months). The study lists 12 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 24 Sep 2026.