AZD7760 for Chronic Kidney Failure

Recruiting at 19 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Systemic antibiotics

Disqualifiers: Hypersensitivity, Bleeding disorders, Malignancy, others

Compensation: Varies

Number of Visits: 3

231 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that no new medications should be added in the two weeks before starting the trial. Adjustments to existing medications are allowed.

What is the purpose of this trial?

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 Criteria

This trial is for healthy adults and those with end-stage kidney disease on hemodialysis via a central venous catheter. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

I am healthy with no significant diseases or medications.

My weight is between 45 and 110 kg, and my BMI is between 18.0 and 30.0.

I have end-stage kidney disease and am on hemodialysis.

Exclusion Criteria

Phase I: Known hypersensitivity to any component of the study intervention

I have no major health issues that could affect my safety in the study.

Phase IIa: Known hypersensitivity to any component of the study intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dosing (Phase I)

Participants receive a single intravenous infusion of AZD7760 or placebo

3 days

1 visit (in-person)

Follow-up (Phase I)

Participants are monitored for safety and pharmacokinetics after the single dose

12 months

Dosing (Phase IIa)

Participants receive two intravenous infusions of AZD7760 or placebo, 3 months apart

6 months

2 visits (in-person)

Follow-up (Phase IIa)

Participants are monitored for safety and pharmacokinetics after the last dose

12 months

Treatment Details

Interventions

• AZD7760

Trial Overview The study tests the safety and how the body processes AZD7760, given intravenously. Phase I involves healthy participants; Phase IIa includes those with severe kidney disease on dialysis.

Participant Groups

Group I: Phase IIa: Study Group 2 (AZD7760 Dose E) Experimental Treatment 1 Intervention

Participants will receive Dose E AZD7760 on Day 1 and Day 91.

Group II: Phase IIa: Study Group 1 (AZD7760 Dose D and Placebo) Experimental Treatment 2 Interventions

Participants will receive Dose D AZD7760 on Day 1 and placebo on Day 91.

Group III: Phase I: Cohort 3 (AZD7760 Dose C and Placebo) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD7760 Dose C or matching placebo intravenously on Day 1.

Group IV: Phase I: Cohort 2 (AZD7760 Dose B and Placebo) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD7760 Dose B or matching placebo intravenously on Day 1.

Group V: Phase I: Cohort 1 (AZD7760 Dose A and Placebo) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD7760 Dose A or matching placebo intravenously on Day 1.

Group VI: Phase IIa: Study Group 3 (Placebo) Placebo Group 1 Intervention

Participants will receive placebo on Day 1 and on Day 91.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland