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
22 september 2026 uppdaterad 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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
84
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: First line of the email MUST contain NCT # and Site #.
Studera Kontakt Backup
- Namn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-post: Clinical.Trials@bms.com
Studieorter
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California
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Anaheim, California, Förenta staterna, 92801
- Rekrytering
- CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
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Kontakt:
- Amina Haggag, Site 0001
- Telefonnummer: 714-774-7777
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Florida
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Bradenton, Florida, Förenta staterna, 34205
- Har inte rekryterat ännu
- Local Institution - 0003
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Kontakt:
- Site 0003
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Daytona Beach, Florida, Förenta staterna, 32117
- Har inte rekryterat ännu
- Local Institution - 0005
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Kontakt:
- Site 0005
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Naples, Florida, Förenta staterna, 34105
- Har inte rekryterat ännu
- Local Institution - 0007
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Kontakt:
- Site 0007
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The Villages, Florida, Förenta staterna, 32162
- Har inte rekryterat ännu
- Local Institution - 0006
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Kontakt:
- Site 0006
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Georgia
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Decatur, Georgia, Förenta staterna, 30030
- Har inte rekryterat ännu
- Local Institution - 0004
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Kontakt:
- Site 0004
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Panel A1: BMS986446
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Specified dose on specified days
Andra namn:
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Experimentell: Panel A2: BMS986446
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Specified dose on specified days
Andra namn:
|
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Experimentell: Panel A3: BMS986446
|
Specified dose on specified days
Andra namn:
|
|
Experimentell: Panel B1: BMS986446
|
Specified dose on specified days
Andra namn:
|
|
Experimentell: Panel B2: BMS986446
|
Specified dose on specified days
Andra namn:
|
|
Experimentell: Panel C1: BMS986446
|
Specified dose on specified days
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: 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
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Maximum observed concentration (Cmax)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Time of maximum observed concentration (Tmax)
Tidsram: 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))
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Area under the serum concentration-time curve from time zero to 672 hours (AUC(0-672))
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
AUC(INF)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Half-life (T-HALF)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Apparent total body clearance in SC administration (CLT/F)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Total body clearance in IV infusion (CLT)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Volume of distribution of terminal phase (VZ)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse events (AEs)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Serious adverse events (SAEs)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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AEs reported as related to BMS-986446
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Incidence of anti-drug antibody (ADA)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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GMR of Panel B1 vs Panel A3 for Cmax
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
|
GMR of Panel B1 vs Panel A3 for area under the concentration-time curve (AUC)
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
|
GMR of Panel B2 vs Panel A3 for Cmax
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
|
GMR of Panel B2 vs Panel A3 for AUC
Tidsram: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Local tolerance evaluation
Tidsram: 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
|
|
Cmax
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1 |
Up to approximately 5 months
|
|
Tmax
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1 |
Up to approximately 5 months
|
|
AUC(0-T)
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2 |
Up to approximately 5 months
|
|
AUC(0-672)
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2 |
Up to approximately 5 months
|
|
AUC(INF)
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2 |
Up to approximately 5 months
|
|
T-HALF
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1 |
Up to approximately 5 months
|
|
CLT/F
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1 |
Up to approximately 5 months
|
|
Vz/F
Tidsram: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1 |
Up to approximately 5 months
|
|
Trough observed plasma concentration (Ctrough)
Tidsram: Up to approximately 5 months
|
Panel C1 |
Up to approximately 5 months
|
|
Concentration at the end of a dosing interval (Ctau)
Tidsram: Up to approximately 5 months
|
Panel C1 |
Up to approximately 5 months
|
|
Area under the concentration-time curve within a dosing interval (AUC(TAU))
Tidsram: Up to approximately 5 months
|
Panel C1 |
Up to approximately 5 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
21 augusti 2026
Primärt slutförande (Beräknad)
17 juni 2027
Avslutad studie (Beräknad)
17 juni 2027
Studieregistreringsdatum
Först inskickad
19 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
19 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CN008-0028
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Tidsram för IPD-delning
See Plan Description
Kriterier för IPD Sharing Access
See Plan Description
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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