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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат AZD7760
  Participants will receive AZD7760 via IV infusion.
• Другое Placebo
  Participants will receive matching placebo via IV infusion.

Первичные конечные точки

• Occurrence of Adverse Events (AEs) [Срок оценки: Day 1 to Day 181]
• Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) [Срок оценки: Day 1 to Day 361]

Вторичные конечные точки (8)

• Maximum observed serum (peak) drug concentration (Cmax) [Срок оценки: Day 1 to Day 361]
• Time to reach peak or maximum observed concentration following drug administration (tmax) [Срок оценки: Day 1 to Day 361]
• Terminal elimination half-life (t½λz) [Срок оценки: Day 1 to Day 361]
• Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) [Срок оценки: Day 1 to Day 361]
• Area under the concentration-time curve from time 0 to infinity (AUCinf) [Срок оценки: Day 1 to Day 361]
• Volume of distribution at steady state (Vss) [Срок оценки: Day 1 to Day 361]
• Volume of distribution based on the terminal phase (Vz) [Срок оценки: Day 1 to Day 361]
• Incidence of Anti-drug antibody (ADA) [Срок оценки: Day 1 to Day 361]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

• 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
• 200 mL whole blood donation within 4 weeks prior to study drug administration.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Япония · 1 центр

• Research Site — Sumida-ku

Идентификаторы

NCT: NCT07612813 · D7480C00003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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