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)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06749457
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Staphylococcus Aureus

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD7760 — DRUG
    Participants will receive AZD7760 as a single intravenous infusion.
  • Placebo — OTHER
    Participants will be administered placebo through intravenous infusion.

Study Details

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).

Key Dates

Start date
Dec 30, 2024
Status verified
Jun 2026
Primary completion
Apr 2, 2027
Completion
Jan 7, 2028

Study Design

Enrollment
231 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Phase I: AZD7760 Dose A
    Participants will receive a single dose of AZD7760 Dose A intravenously on Day 1.
  • Experimental: Phase I: AZD7760 Dose B
    Participants will receive a single dose of AZD7760 Dose B intravenously on Day 1.
  • Experimental: Phase I: AZD7760 Dose C
    Participants will receive a single dose of AZD7760 Dose C intravenously on Day 1.
  • Placebo Comparator: Phase I: Placebo
    Participants will receive a single dose of placebo on Day 1.
  • Experimental: Phase IIa: AZD7760 Dose D and Placebo
    Participants will receive AZD7760 Dose D and placebo on Day 1 on Day 91.
  • Experimental: Phase IIa: AZD7760 Dose E
    Participants will receive AZD7760 Dose E on Day 1 and Day 91.
  • Placebo Comparator: Phase IIa: Placebo
    Participants will receive placebo on Day 1 and on Day 91.

Primary Outcome Measure

Phase I: Occurence of adverse events (AEs) [ Time Frame: Day 1 to Day 181 ]

Central Contacts

Locations (43)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35805-
Research SiteChula VistaCalifornia91910-
Research SiteChula VistaCalifornia91910-
Research SiteGlendaleCalifornia91206-
Research SiteGranada HillsCalifornia91344-
Research SiteLos AngelesCalifornia90027-
Research SiteNorthridgeCalifornia91324-
Research SiteNorthridgeCalifornia91325-
Research SiteOxnardCalifornia93036-
Research SiteRiversideCalifornia92503-
Research SiteSan DimasCalifornia91773-
Research SiteTarzanaCalifornia91356-
Research SiteValenciaCalifornia91355-
Research SiteVictorvilleCalifornia92392-
Research SiteEnglewoodColorado80110-
Research SiteBradentonFlorida34209-
Research SiteCoral SpringsFlorida33071-
Research SiteHollywoodFlorida33024-
Research SiteOrlandoFlorida32806-
Research SiteTampaFlorida33603-
Research SiteLawrencevilleGeorgia30046-
Research SiteChicagoIllinois60640-
Research SiteChicagoIllinois60643-
Research SiteIowa CityIowa52242-
Research SiteLexingtonKentucky40503-
Research SiteBaltimoreMaryland21225-
Research SiteDetroitMichigan48202-
Research SitePontiacMichigan48341-
Research SiteTupeloMississippi38801-
Research SiteKansas CityMissouri64111-
Research SiteLincolnNebraska68510-
Research SiteJersey CityNew Jersey07305-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteRidgewoodNew York11385-
Research SiteKinstonNorth Carolina28504-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteBethlehemPennsylvania18017-
Research SiteKnoxvilleTennessee37923-
Research SiteBeaumontTexas77706-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77074-
Research SiteMcAllenTexas78503-
Research SiteSan AntonioTexas78215-

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