Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
Study NCT ID:
NCT06749457
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-12-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief 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)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAK
Brief 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).
Detailed Description:
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: