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Study of Safety and PK of AZD0543 in Healthy Adults

15. september 2026 oppdatert av: AstraZeneca

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults

The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of AZD0543 in healthy adults 18-55 years of age. 144 participants will be randomized to receive either one of 3 dose levels of AZD0543 or a placebo comparator of the same volume. AZD0543 or placebo will be administered as a single dose on Day 1 via intramuscular (IM) injection or intravenous (IV) infusion. Participants will be followed for approximately 1 year.

Studietype

Intervensjonell

Registrering (Antatt)

144

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Los Alamitos, California, Forente stater, 90720
        • Har ikke rekruttert ennå
        • Research Site
    • Florida
      • South Miami, Florida, Forente stater, 33143
        • Rekruttering
        • Research Site

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

Tar imot friske frivillige

Ja

Beskrivelse

Key Inclusion Criteria:

  • Age 18 to 55 years
  • Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2

Key Exclusion Criteria:

  • Hypersensitivity to IMP/components
  • Severe adverse reaction/hypersensitivity to other mAbs
  • Acute fever/illness/infection within 3 days of planned dosing
  • Clinically important illness/procedure/trauma within 4 weeks of IMP administration
  • Active infection with Hepatitis B/C
  • Clinically significant bleeding disorders
  • Known/suspected immune deficiency/suppression
  • Receipt of blood products/immunoglobulins or immunosuppressive therapies within 6 months prior to screening (immunosuppressive medications/therapies include glucocorticoids exceeding 2 weeks of prednisone (or equivalent) 20mg daily or every other day)
  • Malignancy within previous 5 years; except treated non-melanoma skin cancers and locally treated cervical cancer
  • Receipt of any licensed/investigational hMPV vaccine, other therapies and procedures as applicable; participation in other clinical studies
  • Screening Abnormalities: clinically significant ECG, positive drug panel, Hgb/platelets/WBC outside of reference; all SCr/AST/ALT > 1.5X ULN
  • Women who are pregnant, lactating, or of childbearing potential and not using a highly effective birth control method

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort 1: Low Dose AZD0543
Participants will receive a single AZD0543 dose.
Biologisk: AZD0543
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo komparator: Cohort 1: Placebo
Participants will receive a single dose of placebo.
Annen: Placebo
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
Eksperimentell: Cohort 2: Medium Dose AZD0543
Participants will receive a single AZD0543 dose.
Biologisk: AZD0543
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo komparator: Cohort 2: Placebo
Participants will receive a single dose of placebo.
Annen: Placebo
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
Eksperimentell: Cohort 3: High Dose AZD0543
Participants will receive a single AZD0543 dose.
Biologisk: AZD0543
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo komparator: Cohort 3: Placebo
Participants will receive a single dose of placebo.
Annen: Placebo
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Immediate AEs within 1 hour of IMP administration
Tidsramme: Within 1 hour of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Within 1 hour of IMP administration
Injection/infusion-related reactions
Tidsramme: Within 24 hours of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Within 24 hours of IMP administration
Injection/infusion site reactions
Tidsramme: Through Day 8 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Through Day 8 post-IMP administration
AEs
Tidsramme: Through Day 91 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Through Day 91 post-IMP administration
SAEs, MAAEs, and AESIs
Tidsramme: Throughout the study post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Throughout the study post-IMP administration

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AZD0543 serum concentrations over time
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Cmax
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Tmax
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 t½λz
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUClast
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUCinf
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 CL
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vss
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vz
Tidsramme: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
To assess the pharmacokinetics (PK) of AZD0543, in serum
Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
Incidence of ADA; magnitude of ADA response
Tidsramme: Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
To assess anti-drug antibody (ADA) responses to AZD0543 in serum
Study Day 1 baseline; Study Day 8, 31, 91, 151, 361

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

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 (Faktiske)

31. august 2026

Primær fullføring (Antatt)

24. mars 2027

Studiet fullført (Antatt)

20. desember 2027

Datoer for studieregistrering

Først innsendt

28. august 2026

Først innsendt som oppfylte QC-kriteriene

15. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • D9190C00002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tilgangskriterier for IPD-deling

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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