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 oppdatert av: 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
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
84
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Studer Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-post: Clinical.Trials@bms.com
Studiesteder
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California
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Anaheim, California, Forente stater, 92801
- Local Institution - 0001
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Ta kontakt med:
- Site 0001
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Panel A1: BMS986446
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Spesifisert dose på angitte dager
Andre navn:
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Eksperimentell: Panel A2: BMS986446
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Spesifisert dose på angitte dager
Andre navn:
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Eksperimentell: Panel A3: BMS986446
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Spesifisert dose på angitte dager
Andre navn:
|
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Eksperimentell: Panel B1: BMS986446
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Spesifisert dose på angitte dager
Andre navn:
|
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Eksperimentell: Panel B2: BMS986446
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Spesifisert dose på angitte dager
Andre navn:
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Eksperimentell: Panel C1: BMS986446
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Spesifisert dose på angitte dager
Andre navn:
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Hva måler studien?
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
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Up to approximately 5 months
|
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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
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Up to approximately 5 months
|
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Time of maximum observed concentration (Tmax)
Tidsramme: Up to approximately 5 months
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Up to approximately 5 months
|
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Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Tidsramme: Up to approximately 5 months
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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
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Up to approximately 5 months
|
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AUC(INF)
Tidsramme: Up to approximately 5 months
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Up to approximately 5 months
|
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Half-life (T-HALF)
Tidsramme: Up to approximately 5 months
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Up to approximately 5 months
|
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Apparent total body clearance in SC administration (CLT/F)
Tidsramme: Up to approximately 5 months
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Up to approximately 5 months
|
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Total body clearance in IV infusion (CLT)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
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Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
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Volume of distribution of terminal phase (VZ)
Tidsramme: Up to approximately 5 months
|
Up to approximately 5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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.
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Up to approximately 5 months
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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
|
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Cmax
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
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Tmax
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
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AUC(0-T)
Tidsramme: Up to approximately 5 months
|
Panel B1, Panel B2
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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
|
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Trough observed plasma concentration (Ctrough)
Tidsramme: Up to approximately 5 months
|
Panel C1
|
Up to approximately 5 months
|
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Concentration at the end of a dosing interval (Ctau)
Tidsramme: Up to approximately 5 months
|
Panel C1
|
Up to approximately 5 months
|
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
21. august 2026
Primær fullføring (Antatt)
17. juni 2027
Studiet fullført (Antatt)
17. juni 2027
Datoer for studieregistrering
Først innsendt
19. august 2026
Først innsendt som oppfylte QC-kriteriene
19. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CN008-0028
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Tilgangskriterier for IPD-deling
See Plan Description
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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