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 aktualisiert von: 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
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
84
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: First line of the email MUST contain NCT # and Site #.
Studieren Sie die Kontaktsicherung
- Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-Mail: Clinical.Trials@bms.com
Studienorte
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California
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Anaheim, California, Vereinigte Staaten, 92801
- Local Institution - 0001
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Kontakt:
- Site 0001
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Panel A1: BMS986446
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Angegebene Dosis an bestimmten Tagen
Andere Namen:
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Experimental: Panel A2: BMS986446
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Angegebene Dosis an bestimmten Tagen
Andere Namen:
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Experimental: Panel A3: BMS986446
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Angegebene Dosis an bestimmten Tagen
Andere Namen:
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Experimental: Panel B1: BMS986446
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Angegebene Dosis an bestimmten Tagen
Andere Namen:
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Experimental: Panel B2: BMS986446
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Angegebene Dosis an bestimmten Tagen
Andere Namen:
|
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Experimental: Panel C1: BMS986446
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Angegebene Dosis an bestimmten Tagen
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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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
Zeitfenster: 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
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
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Maximum observed concentration (Cmax)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
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Time of maximum observed concentration (Tmax)
Zeitfenster: Up to approximately 5 months
|
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))
Zeitfenster: 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))
Zeitfenster: Up to approximately 5 months
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Up to approximately 5 months
|
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AUC(INF)
Zeitfenster: Up to approximately 5 months
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Up to approximately 5 months
|
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Half-life (T-HALF)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Apparent volume of distribution of terminal phase in SC administration (Vz/F)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
Volume of distribution of terminal phase (VZ)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Adverse events (AEs)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Serious adverse events (SAEs)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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AEs reported as related to BMS-986446
Zeitfenster: Up to approximately 5 months
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Up to approximately 5 months
|
|
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Incidence of anti-drug antibody (ADA)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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Local tolerance evaluation
Zeitfenster: 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
|
|
GMR of Panel B1 vs Panel A3 for Cmax
Zeitfenster: 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)
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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GMR of Panel B2 vs Panel A3 for Cmax
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
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GMR of Panel B2 vs Panel A3 for AUC
Zeitfenster: Up to approximately 5 months
|
Up to approximately 5 months
|
|
|
Cmax
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
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Up to approximately 5 months
|
|
Tmax
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
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AUC(0-T)
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2
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Up to approximately 5 months
|
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AUC(0-672)
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2
|
Up to approximately 5 months
|
|
AUC(INF)
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2
|
Up to approximately 5 months
|
|
T-HALF
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
CLT/F
Zeitfenster: Up to approximately 5 months
|
Panel B1, Panel B2, Panel C1
|
Up to approximately 5 months
|
|
Vz/F
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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))
Zeitfenster: Up to approximately 5 months
|
Panel C1
|
Up to approximately 5 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
21. August 2026
Primärer Abschluss (Geschätzt)
17. Juni 2027
Studienabschluss (Geschätzt)
17. Juni 2027
Studienanmeldedaten
Zuerst eingereicht
19. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. August 2026
Zuerst gepostet (Tatsächlich)
21. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CN008-0028
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
See Plan Description
IPD-Sharing-Zugriffskriterien
See Plan Description
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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