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

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

∙ 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 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:

‣ 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 90 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.

Locations
United States
Alabama
Research Site
NOT_YET_RECRUITING
Huntsville
California
Research Site
RECRUITING
Glendale
Research Site
NOT_YET_RECRUITING
Granada Hills
Research Site
NOT_YET_RECRUITING
La Mesa
Research Site
NOT_YET_RECRUITING
Los Angeles
Research Site
NOT_YET_RECRUITING
Northridge
Research Site
NOT_YET_RECRUITING
Northridge
Research Site
NOT_YET_RECRUITING
Oxnard
Research Site
NOT_YET_RECRUITING
Riverside
Research Site
RECRUITING
San Dimas
Research Site
NOT_YET_RECRUITING
Tarzana
Research Site
NOT_YET_RECRUITING
Valencia
Research Site
RECRUITING
Victorville
Colorado
Research Site
NOT_YET_RECRUITING
Englewood
Florida
Research Site
NOT_YET_RECRUITING
Bradenton
Research Site
NOT_YET_RECRUITING
Coral Springs
Research Site
NOT_YET_RECRUITING
Hollywood
Research Site
NOT_YET_RECRUITING
Orlando
Research Site
NOT_YET_RECRUITING
Tampa
Iowa
Research Site
NOT_YET_RECRUITING
Iowa City
Illinois
Research Site
NOT_YET_RECRUITING
Chicago
Research Site
WITHDRAWN
Chicago
Maryland
Research Site
RECRUITING
Baltimore
Michigan
Research Site
NOT_YET_RECRUITING
Detroit
Research Site
NOT_YET_RECRUITING
Pontiac
Missouri
Research Site
NOT_YET_RECRUITING
Kansas City
Mississippi
Research Site
NOT_YET_RECRUITING
Tupelo
North Carolina
Research Site
WITHDRAWN
Kinston
Research Site
RECRUITING
Winston-salem
Nebraska
Research Site
NOT_YET_RECRUITING
Lincoln
New Jersey
Research Site
NOT_YET_RECRUITING
Jersey City
New Mexico
Research Site
RECRUITING
Albuquerque
New York
Research Site
RECRUITING
Ridgewood
Pennsylvania
Research Site
RECRUITING
Bethlehem
Tennessee
Research Site
WITHDRAWN
Knoxville
Texas
Research Site
RECRUITING
Beaumont
Research Site
NOT_YET_RECRUITING
Dallas
Research Site
NOT_YET_RECRUITING
Houston
Research Site
NOT_YET_RECRUITING
Mcallen
Research Site
NOT_YET_RECRUITING
San Antonio
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2027-07-06
Participants
Target number of participants: 231
Treatments
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.
Sponsors
Leads: AstraZeneca
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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