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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Drug AZD7760
  Participants will receive AZD7760 via IV infusion.
• Other Placebo
  Participants will receive matching placebo via IV infusion.

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

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:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Japan · 1 center

• Research Site — Sumida-ku

Identifiers

NCT: NCT07612813 · D7480C00003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗