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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
231
Phase I: Occurence of adverse events (AEs)
To evaluate the safety of AZD7760 administered as a single intravenous (IV) Dose A, B, or C.
Time frame: 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.
Time frame: 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
Time frame: Day 1 to Day 181
Phase I: Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the pharmacokinetics (PK) of AZD7760 in serum.
Time frame: 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.
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)
To characterize the PK of AZD7760 in serum.
Time frame: 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.
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Research Site
Huntsville, Alabama, United States
RECRUITINGResearch Site
Chula Vista, California, United States
WITHDRAWNResearch Site
Chula Vista, California, United States
RECRUITINGResearch Site
Glendale, California, United States
RECRUITINGResearch Site
Granada Hills, California, United States
NOT_YET_RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Northridge, California, United States
RECRUITINGResearch Site
Northridge, California, United States
RECRUITINGResearch Site
Oxnard, California, United States
RECRUITINGResearch Site
Riverside, California, United States
RECRUITING...and 31 more locations
Time frame: 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.
Time frame: Day 1 to Day 361
Phase I: Apparent volume of distribution at steady state (Vss)
To characterize the PK of AZD7760 in serum.
Time frame: Day 1 to Day 361
Phase I: Apparent volume of distribution at the terminal phase (Vz)
To characterize the PK of AZD7760 in serum.
Time frame: Day 1 to Day 361
Phase I: Incidence of ADA
To evaluate ADA responses to AZD7760 in serum.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 451