The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).
Participant must be 18 to 55 years of age (inclusive), at the time of signing the informed consent.
Body weight ≥ 45 kilograms (kg) and ≤ 110 kg and Body Mass Index (BMI) within the range ≥ 18.0 to ≤ 30.0 kilograms per square meter (kg/m2) (inclusive) at screening.
Healthy participants with no clinically significant concomitant diseases or medications (except for those specifically permitted by the protocol) according to medical history, physical examination, screening safety laboratory tests, and screening parameters, as perthe judgement of the investigator.
Participant must be ≥ 18 years of age at the time of signing the informed consent.
Known hypersensitivity to any component of the study intervention
Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal antibodies (mAbs).
Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) above 1.5 × upper limit of normal (ULN) at screening. Testing may be repeated once at the investigator's discretion.
Parallel
AZD7760
DrugParticipants will receive AZD7760 as a single intravenous infusion.
Placebo
Other interventionParticipants will be administered placebo through intravenous infusion.
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Treatment groupsSee each treatment group below.
Phase I: Occurence of adverse events (AEs)
To evaluate the safety of AZD7760 administered as a single intravenous (IV) Dose A, B, or C.
Phase I: Occurence of medically-attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
To evaluate the safety of AZD7760 administered as a single IV Dose A, B, or C.
Phase IIa: Occurrence of AEs, MAAEs, SAEs, and AESIs
To evaluate the safety of AZD7760 compared with placebo as: * A single IV dose (at Day 1) of Dose D followed by placebo (at Day 91) * 2 IV doses (at Day 1 and Day 91) of Dose E
Phase I: Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the pharmacokinetics (PK) of AZD7760 in serum.
Phase I: Time to reach peak or maximum observed concentration following drug administration (tmax)
To characterize the PK of AZD7760 in serum.
Phase I: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
To characterize the PK of AZD7760 in serum.
Phase I: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the PK of AZD7760 in serum.
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AstraZeneca
Lead sponsor
Parexel
Collaborator
