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Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease

NCT07228364 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-11

No results posted yet for this study

Summary

A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).

Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Interventions

DRUG

AZD1613 - Part A

Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.

DRUG

Placebo - Part A

Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.

DRUG

AZD1613 - Part B

Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.

DRUG

Placebo - Part B

Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2027-01-26
Completion
2027-01-26
FDA Drug
Yes

Countries

  • United States
  • China
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07228364 on ClinicalTrials.gov