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Study of Safety and PK of AZD0543 in Healthy Adults

15 september 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

144

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Los Alamitos, California, Förenta staterna, 90720
        • Har inte rekryterat ännu
        • Research Site
    • Florida
      • South Miami, Florida, Förenta staterna, 33143
        • Rekrytering
        • Research Site

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

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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-jämförare: Cohort 1: Placebo
Participants will receive a single dose of placebo.
Övrig: 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.
Experimentell: 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-jämförare: Cohort 2: Placebo
Participants will receive a single dose of placebo.
Övrig: 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.
Experimentell: 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-jämförare: Cohort 3: Placebo
Participants will receive a single dose of placebo.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Immediate AEs within 1 hour of IMP administration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
AZD0543 serum concentrations over time
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

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)

31 augusti 2026

Primärt slutförande (Beräknad)

24 mars 2027

Avslutad studie (Beräknad)

20 december 2027

Studieregistreringsdatum

Först inskickad

28 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

15 september 2026

Första postat (Faktisk)

17 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • D9190C00002

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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