Staphylococcus AureusPhase 1/2PEAKNCT06749457
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)
A Phase 1/2 study testing AZD7760 in people with Staphylococcus Aureus, run by AstraZeneca at 40 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- AZD7760
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 40 sitesUnited States
- Study dates
- 30 Dec 2024to 13 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Phase I:
- 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 per the judgement of the investigator.
- Phase IIa:
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
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- Participants who meet all of the following disease status requirements:
- Diagnosed with End-stage kidney disease (ESKD).
- Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis.
- Receiving hemodialysis for treatment of ESKD for at least 60 days before randomization.
- At least 3 previous dialysis sessions using current dialyzer.
- Receiving adequate hemodialysis based on a single-pool Kt/V measurement > 1.2 within the last 30 days.
- No new medications have been added to the participant's regimen in the last 2 weeks prior to dosing. 'New medication' is defined as any medication that has not been prescribed or used by the participant previously (including formulation changes). Medication previously prescribed or used by the participant with dose adjustments is allowed and not considered as new medication for the purpose of this study.
- Not taking long-term systemic antibiotics with activity against S aureus.
Who cannot join
- Phase I:
- 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.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at screening.
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- Hemoglobin or platelet count below the lower limit of normal at screening. Testing may be repeated once at the investigator's discretion.
- White blood cell counts outside normal reference ranges unless judged by the investigator to be out of range given the known variation in white blood cell count reference interval by ethnicity. Testing may be repeated once at the investigator's discretion.
- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
- 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.
- Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
- Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the 28-day Screening Period or may be rescreened once.
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
- Any condition that has the potential to increase clearance of the study intervention (eg, protein loss conditions such as severe enteropathies, or plasmapheresis).
- Blood drawn in excess of a total of 450 milliliters (mL) (1 unit) for any reason within 2 months prior to screening.
- Absence of suitable veins for blood sampling and administration of study intervention.
- Any other condition that would compromise safety of the participants.
- Any condition that, in the opinion of the investigator, might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
- Phase IIa:
- Known hypersensitivity to any component of the study intervention.
- History of allergic disease or reactions likely to be exacerbated by any component of the study intervention as listed in dose formulation section.
- Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
- Hemoglobin < 9 g/dL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion.
- Serum albumin of < 3 g/dL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion.
- Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 90 days prior to randomization.
- Known S aureus infection within 90 days of study entry.
- Known acute viral or bacterial infection or symptoms/signs consistent with such an infection within the 21 days prior to infusion or study intervention. Mild intercurrent viral illness with a temperature of 38.1 °C (100.6 °F) or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the mAb.
- Participants with malignancy undergoing chemotherapy.
- Scheduled date for living donor kidney transplant.
- Plans to switch to peritoneal dialysis within the primary endpoint time period (181 days).
- Regarding arteriovenous fistula (AVF) or arteriovenous graft (AVG):
- Future AVG or AVG: (i) Participants with central venous catheters currently in use for dialysis, and future plans for AVF or AVG use within 90 days of randomization are not eligible.
- Participants with central venous catheters currently in use for dialysis, and future plans for AVF or AVG placement, but no plans for AVF or AVG use within 90 days of randomization are eligible.
- Existing AVG or AVG: (i) Participants with central venous catheters in use for dialysis, but also with an existing AVF or AVG that is not in use and with no future plans for use are eligible.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Research Site
Albuquerque, New Mexico, 87109
Research Site
Baltimore, Maryland, 21225
Research Site
Beaumont, Texas, 77706
Research Site
Bethlehem, Pennsylvania, 18017
Research Site
Bradenton, Florida, 34209
Research Site
Chicago, Illinois, 60640
Research Site
Chicago, Illinois, 60643
Research Site
Chula Vista, California, 91910
Research Site
Coral Springs, Florida, 33071
Research Site
Dallas, Texas, 75246
Research Site
Detroit, Michigan, 48202
Research Site
Englewood, Colorado, 80110
Research Site
Glendale, California, 91206
Research Site
Granada Hills, California, 91344
Research Site
Hollywood, Florida, 33024
Research Site
Houston, Texas, 77074
Research Site
Huntsville, Alabama, 35805
Research Site
Iowa City, Iowa, 52242
Research Site
Jersey City, New Jersey, 07305
Research Site
Kansas City, Missouri, 64111
Research Site
Las Vegas, Nevada, 89128
Research Site
Lawrenceville, Georgia, 30046
Research Site
Lexington, Kentucky, 40503
Research Site
Lincoln, Nebraska, 68510
Research Site
Los Angeles, California, 90027
Research Site
McAllen, Texas, 78503
Research Site
Northridge, California, 91324
Research Site
Northridge, California, 91325
Research Site
Orlando, Florida, 32806
Research Site
Oxnard, California, 93036
Research Site
Pontiac, Michigan, 48341
Research Site
Ridgewood, New York, 11385
Research Site
Riverside, California, 92503
Research Site
San Dimas, California, 91773
Research Site
Tampa, Florida, 33603
Research Site
Tarzana, California, 91356
Research Site
Tupelo, Mississippi, 38801
Research Site
Valencia, California, 91355
Research Site
Victorville, California, 92392
Research Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase I/IIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Participants and in Patients With End-stage Kidney Disease Receiving Hemodialysis Through a Central Venous Catheter
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).
Read the detailed description
In the Phase I portion of the study, participants will be randomized to receive one of 3 dosages of AZD7760 or placebo as a single intravenous infusion.
Study details include:
- A 28-day Screening Period.
- A Dosing Period of 3 days in which a single intravenous infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
In the Phase IIa portion of the study, participants will be randomized to receive either AZD7760 or placebo as 2 intravenous infusions given 3 months apart.
Study details include:
- A 28-day Screening Period.
- A Dosing Period in which 2 intravenous infusions will be given 3 months apart (Day 1 and Day 91).
- A Follow-up Period of 12 months after the last administration of the study intervention on Day 91.
- Conditions
- Staphylococcus Aureus
- Being tested
- AZD7760, Placebo
- Keywords
- Bloodstream infection, End-stage kidney disease
- Medical subject headings
- Staphylococcal Infections, Sepsis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7760Drug
Participants will receive AZD7760 as a single intravenous infusion.
PlaceboOther
Participants will be administered placebo through intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: AZD7760 Dose A | Experimental | Participants will receive a single dose of AZD7760 Dose A intravenously on Day 1. Receives: Drug: AZD7760 |
| Phase I: AZD7760 Dose B | Experimental | Participants will receive a single dose of AZD7760 Dose B intravenously on Day 1. Receives: Drug: AZD7760 |
| Phase I: AZD7760 Dose C | Experimental | Participants will receive a single dose of AZD7760 Dose C intravenously on Day 1. Receives: Drug: AZD7760 |
| Phase I: Placebo | Placebo comparator | Participants will receive a single dose of placebo on Day 1. Receives: Other: Placebo |
| Phase IIa: AZD7760 Dose D and Placebo | Experimental | Participants will receive AZD7760 Dose D and placebo on Day 1 on Day 91. Receives: Drug: AZD7760; Other: Placebo |
| Phase IIa: AZD7760 Dose E | Experimental | Participants will receive AZD7760 Dose E on Day 1 and Day 91. Receives: Drug: AZD7760 |
| Phase IIa: Placebo | Placebo comparator | Participants will receive placebo on Day 1 and on Day 91. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Occurence of adverse events (AEs)
To evaluate the safety of AZD7760 administered as a single intravenous (IV) Dose A, B, or C.
Measured: Day 1 to Day 181
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.
Measured: Day 1 to Day 361
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
Measured: Day 1 to Day 181
Secondary outcomes (18)
Phase I: Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the pharmacokinetics (PK) of AZD7760 in serum.
Measured: Day 1 to Day 361
Phase I: Time to reach peak or maximum observed concentration following drug administration (tmax)
To characterize the PK of AZD7760 in serum.
Measured: Day 1 to Day 361
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.
Measured: Day 1 to Day 361
Phase I: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the PK of AZD7760 in serum.
Measured: Day 1 to Day 361
Phase I: Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
To characterize the PK of AZD7760 in serum.
Measured: Day 1 to Day 361
Phase I: Apparent volume of distribution at steady state (Vss)
To characterize the PK of AZD7760 in serum.
Measured: Day 1 to Day 361
Phase I: Apparent volume of distribution at the terminal phase (Vz)
To characterize the PK of AZD7760 in serum.
Measured: Day 1 to Day 361
Phase I: Incidence of ADA
To evaluate ADA responses to AZD7760 in serum.
Measured: Day 1 to Day 361
Phase IIa: Cmax
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: tmax
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: t1/2λz
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: AUClast
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: AUCinf
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Vss
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Vz
To characterize the serum PK profiles of AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Incidence of anti-drug antibodies (ADAs) to AZD7760 in serum
To evaluate ADA responses to AZD7760 administered 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
Measured: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Occurrence of AEs
To evaluate the safety to Day 181 of AZD7760 administered 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
Measured: Day 1 to Day 181
Phase IIa: Occurrence of MAAEs, SAEs, and AESIs
To evaluate the safety to Day 451 of AZD7760 administered 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
Measured: Day 1 to Day 451
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Dec 2024
- Primary completion8 Mar 2027 (estimated)
- Study completion13 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749457
- Sponsor's protocol ID
- D7480C00001
- Acronym
- PEAK
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Participants and in Patients With End-stage Kidney Disease Receiving Hemodialysis Through a Central Venous Catheter
- ClinicalTrials.gov ID
- NCT06749457
- Acronym / sponsor ID
- PEAK / D7480C00001
- Conditions
- Staphylococcus Aureus
- Keywords
- Bloodstream infection, End-stage kidney disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 242 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 13 Dec 2027 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In the Phase I portion of the study, participants will be randomized to receive one of 3 dosages of AZD7760 or placebo as a single intravenous infusion.
Study details include:
- A 28-day Screening Period.
- A Dosing Period of 3 days in which a single intravenous infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
In the Phase IIa portion of the study, participants will be randomized to receive either AZD7760 or placebo as 2 intravenous infusions given 3 months apart.
Study details include:
- A 28-day Screening Period.
- A Dosing Period in which 2 intravenous infusions will be given 3 months apart (Day 1 and Day 91).
- A Follow-up Period of 12 months after the last administration of the study intervention on Day 91.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase I: AZD7760 Dose A | Experimental | Drug: AZD7760Participants will receive a single dose of AZD7760 Dose A intravenously on Day 1. |
| Phase I: AZD7760 Dose B | Experimental | Drug: AZD7760Participants will receive a single dose of AZD7760 Dose B intravenously on Day 1. |
| Phase I: AZD7760 Dose C | Experimental | Drug: AZD7760Participants will receive a single dose of AZD7760 Dose C intravenously on Day 1. |
| Phase I: Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo on Day 1. |
| Phase IIa: AZD7760 Dose D and Placebo | Experimental | Drug: AZD7760, Other: PlaceboParticipants will receive AZD7760 Dose D and placebo on Day 1 on Day 91. |
| Phase IIa: AZD7760 Dose E | Experimental | Drug: AZD7760Participants will receive AZD7760 Dose E on Day 1 and Day 91. |
| Phase IIa: Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo on Day 1 and on Day 91. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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 per the judgement of the investigator.
- 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:
Key exclusion criteria (34 listed)
- 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.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7760Participants will receive AZD7760 as a single intravenous infusion. | Drug | Phase I: AZD7760 Dose A, Phase I: AZD7760 Dose B, Phase I: AZD7760 Dose C, Phase IIa: AZD7760 Dose D and Placebo, Phase IIa: AZD7760 Dose E |
| PlaceboParticipants will be administered placebo through intravenous infusion. | Other | Phase I: Placebo, Phase IIa: AZD7760 Dose D and Placebo, Phase IIa: Placebo |
Primary outcome
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
18 secondary outcomes
Phase I: Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1 to Day 361
Phase I: Time to reach peak or maximum observed concentration following drug administration (tmax)
Time frame: Day 1 to Day 361
Phase I: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Time frame: Day 1 to Day 361
Phase I: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 361
Phase I: Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
Time frame: Day 1 to Day 361
Phase I: Apparent volume of distribution at steady state (Vss)
Time frame: Day 1 to Day 361
Phase I: Apparent volume of distribution at the terminal phase (Vz)
Time frame: Day 1 to Day 361
Phase I: Incidence of ADA
Time frame: Day 1 to Day 361
Phase IIa: Cmax
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: tmax
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: t1/2λz
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: AUClast
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: AUCinf
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Vss
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Vz
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Incidence of anti-drug antibodies (ADAs) to AZD7760 in serum
Time frame: Day 1 to Day 181 and Day 1 to Day 451
Phase IIa: Occurrence of AEs
Time frame: Day 1 to Day 181
Phase IIa: Occurrence of MAAEs, SAEs, and AESIs
Time frame: Day 1 to Day 451
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD7760 in people with Staphylococcus Aureus, run by AstraZeneca at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Occurence of adverse events (AEs) (time frame: Day 1 to Day 181). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.