Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1671
Source ID: NCT06749457
Associated Drug: Azd7760
Title: 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)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Staphylococcus Aureus
Interventions: DRUG: AZD7760|OTHER: Placebo
Outcome Measures: Primary: Phase I: Occurence of adverse events (AEs), To evaluate the safety of AZD7760 administered as a single intravenous (IV) Dose A, B, or C., 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., 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, Day 1 to Day 181 | Secondary: Phase I: Maximum observed plasma (peak) drug concentration (Cmax), To characterize the pharmacokinetics (PK) of AZD7760 in serum., 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., 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., 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., 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., Day 1 to Day 361|Phase I: Apparent volume of distribution at steady state (Vss), To characterize the PK of AZD7760 in serum., Day 1 to Day 361|Phase I: Apparent volume of distribution at the terminal phase (Vz), To characterize the PK of AZD7760 in serum., Day 1 to Day 361|Phase I: Incidence of ADA, To evaluate ADA responses to AZD7760 in serum., 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, Day 181 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, Day 181 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, Day 181 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, Day 181 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, Day 181 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, Day 181 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, Day 181 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, Day 181 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, 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, Day 1 to Day 451
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel
Gender: ALL
Age: ADULT
Phases: PHASE1|PHASE2
Enrollment: 231
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-12-30
Completion Date: 2027-07-06
Results First Posted:
Last Update Posted: 2025-03-26
Locations: Research Site, Glendale, California, 91206, United States|Research Site, Los Angeles, California, 90027, United States|Research Site, Tarzana, California, 91356, United States|Research Site, Baltimore, Maryland, 21225, United States|Research Site, Albuquerque, New Mexico, 87109, United States
URL: https://clinicaltrials.gov/show/NCT06749457