NCT06749457 · AstraZeneca
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
(PEAK)
What this study is about
The purpose of this study is to evaluate the safety and how the drug moves through the body (PK) of AZD7760 when given as an given through a vein (IV) infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).
View original scientific description
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).
Interventions
DRUG
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
OTHER
Placebo
Participants will be administered placebo through intravenous infusion.
Primary outcome measures
Phase I: Occurence of adverse events (AEs)
Time frame: Day 1 to Day 181
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)
Time frame: Day 1 to Day 361
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
Time frame: Day 1 to Day 181
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Phase IIa:
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
- Participants who meet all of the following disease status requirements: 1. Diagnosed with End-stage kidney disease (ESKD). 2. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis. 3. Receiving hemodialysis for treatment of ESKD f
Where
- Huntsville, Alabama
- Chula Vista, California
- Glendale, California
- Granada Hills, California
- Los Angeles, California
- Northridge, California
- Oxnard, California
- Riverside, California
- San Dimas, California
- Tarzana, California
- Valencia, California
- Victorville, California
And 28 more locations — see the full list below.
Collaborators
Parexel
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations