About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AZD7760
- Placebo
Treatment groups
7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
AstraZeneca
Lead sponsor
Parexel
Collaborator