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A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults

5 oktober 2026 uppdaterad av: AstraZeneca

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants

The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.

Studieöversikt

Status

Aktiv, inte rekryterande

Detaljerad beskrivning

This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.

Study details include:

  • A Screening Period of up to 28 days.
  • A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
  • A Follow-up Period of 12 months from the time of administration of the study intervention.

Studietyp

Interventionell

Inskrivning (Faktisk)

18

Fas

  • Fas 1

Kontakter och platser

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

Studieorter

      • Sumida-ku, Japan, 130-0004
        • 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

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
  • Healthy Japanese participants with no clinically significant concomitant diseases or medications.

Exclusion Criteria:

  • Known hypersensitivity to any component of the study intervention.

  • Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.

  • Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.

  • AST or ALT above 1.5 × ULN at screening.

  • Estimated glomerular filtration rate < 90 mL/min/1.73 m2.

  • Hemoglobin or platelet count below the lower limit of normal at screening.

  • White blood cell counts outside normal reference ranges.

  • History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.

  • Any clinically significant abnormalities on 12-lead ECG at screening,

  • Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.

  • Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.

  • Any condition that has the potential to increase clearance of the study intervention.

  • Blood donation or collection as follows:

    1. 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
    2. 200 mL whole blood donation within 4 weeks prior to study drug administration.
    3. Apheresis donation within 2 weeks prior to study drug administration.
  • Absence of suitable veins for blood sampling and administration of study intervention.

  • Any other condition that would compromise the safety of the participants.

  • Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.

  • Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.

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: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cohort 1 (AZD7760 Dose A)

Participants receive an IV infusion of AZD7760 Dose A on Day 1.

Participants will receive AZD7760 via IV infusion.

Experimentell: Cohort 2 (AZD7760 Dose B)

Participants receive an IV infusion of AZD7760 Dose B on Day 1.

Participants will receive AZD7760 via IV infusion.

Placebo-jämförare: Pooled Placebo

Participants receive an IV infusion of matching placebo on Day 1.

Participants will receive matching placebo via IV infusion.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Occurrence of Adverse Events (AEs)
Tidsram: Day 1 to Day 181

To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.

Day 1 to Day 181
Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Tidsram: Day 1 to Day 361

To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.

Day 1 to Day 361

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum observed serum (peak) drug concentration (Cmax)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Time to reach peak or maximum observed concentration following drug administration (tmax)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Terminal elimination half-life (t½λz)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Volume of distribution at steady state (Vss)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Volume of distribution based on the terminal phase (Vz)
Tidsram: Day 1 to Day 361

To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.

Day 1 to Day 361
Incidence of Anti-drug antibody (ADA)
Tidsram: Day 1 to Day 361

To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants

Day 1 to Day 361

Samarbetspartners och utredare

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

Sponsor

Samarbetspartners

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)

29 juni 2026

Primärt slutförande (Beräknad)

13 september 2027

Avslutad studie (Beräknad)

13 september 2027

Studieregistreringsdatum

Först inskickad

21 maj 2026

Först inskickad som uppfyllde QC-kriterierna

21 maj 2026

Första postat (Faktisk)

29 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 oktober 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • D7480C00003

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 is accepting requests for IPD, but this does not mean all requests will be approved.

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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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