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
19. august 2026 opdateret af: Bristol-Myers Squibb
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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
84
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
-
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California
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Anaheim, California, Forenede Stater, 92801
- Local Institution - 0001
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Kontakt:
- Site 0001
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Panel A1: BMS986446
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Specificeret dosis på specificerede dage
Andre navne:
|
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Eksperimentel: Panel A2: BMS986446
|
Specificeret dosis på specificerede dage
Andre navne:
|
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Eksperimentel: Panel A3: BMS986446
|
Specificeret dosis på specificerede dage
Andre navne:
|
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Eksperimentel: Panel B1: BMS986446
|
Specificeret dosis på specificerede dage
Andre navne:
|
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Eksperimentel: Panel B2: BMS986446
|
Specificeret dosis på specificerede dage
Andre navne:
|
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Eksperimentel: Panel C1: BMS986446
|
Specificeret dosis på specificerede dage
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Absolute bioavailability estimated from GMR of AUC(INF) of BMS-986446 after intravenous (IV) infusion
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
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Maximum observed concentration (Cmax)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Time of maximum observed concentration (Tmax)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
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Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
AUC(INF)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Half-life (T-HALF)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Apparent total body clearance in SC administration (CLT/F)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Total body clearance in IV infusion (CLT)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Volume of distribution of terminal phase (VZ)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events (AEs)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Serious adverse events (SAEs)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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AEs reported as related to BMS-986446
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Incidence of anti-drug antibody (ADA)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Local tolerance evaluation
Tidsramme: Up to approximately 5 months
|
This evaluation will assess pain, itching, burning, pressure, and soreness/tenderness (using a Numeric Rating Scale) at the injection site location.
|
Up to approximately 5 months
|
|
GMR of Panel B1 vs Panel A3 for Cmax
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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GMR of Panel B2 vs Panel A3 for Cmax
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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GMR of Panel B2 vs Panel A3 for AUC
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
|
|
Cmax
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
Tmax
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
AUC(0-T)
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2
|
Up to approximately 5 months
|
|
AUC(0-672)
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2
|
Up to approximately 5 months
|
|
AUC(INF)
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2
|
Up to approximately 5 months
|
|
T-HALF
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
CLT/F
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
Vz/F
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
Trough observed plasma concentration (Ctrough)
Tidsramme: Up to approximately 5 months
|
Panel C1
|
Up to approximately 5 months
|
|
Concentration at the end of a dosing interval (Ctau)
Tidsramme: Up to approximately 5 months
|
Panel C1
|
Up to approximately 5 months
|
|
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Tidsramme: Up to approximately 5 months
|
Panel C1
|
Up to approximately 5 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
21. august 2026
Primær færdiggørelse (Anslået)
17. juni 2027
Studieafslutning (Anslået)
17. juni 2027
Datoer for studieregistrering
Først indsendt
19. august 2026
Først indsendt, der opfyldte QC-kriterier
19. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CN008-0028
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.html
IPD-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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