Recruiting
Phase 1

AZD1613

Sponsor:

AstraZeneca

Code:

NCT07228364

Conditions

Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

AZD1613 - Part A

Placebo - Part A

AZD1613 - Part B

Placebo - Part B

Study Details

Brief 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

Study ID

NCT07228364

Start date

Nov 10, 2025

Status verified date

Jul, 2026

Completion date

May 22, 2027

Anticipated

Primary completion date

May 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes
  • eGFR = 45 to 90 mL/min /1.73m2
  • Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive).
  • Females are to be of non-childbearing potential

Exclusion Criteria:

  • As judged by the investigator, any evidence of cardiac, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the participant to participate in the study.
  • Positive hepatitis C antibody, hepatitis B virus surface antigen, or human immunodeficiency virus test, at screening.
  • History of QT prolongation associated with other medications that required discontinuation of that medication.
  • Congenital long QT syndrome.
  • History of ventricular arrhythmia requiring treatment. Patients with atrial fibrillation/flutter and controlled ventricular rate HR < 100 bpm can be eligible as judged by the investigator.
  • Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator.
  • Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator.
  • Systolic BP > 160 mmHg or diastolic BP > 100mmHg or HR < 50 bpm or > 100 bpm at screening. Patients taking anti-hypertensive medication should be on a stable treatment regimen of antihypertensive therapy for at least 30 days prior to the screening visit.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
  • Kidney cyst interventions such as cyst aspiration or cyst fenestration within 12 weeks prior to screening and during the screening period, or such interventions planned or anticipated within the follow-up period.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - Cohort A1

Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.

experimental: Part A - Cohort A2

Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.

experimental: Part B - Chinese Cohort

Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85.

Interventions

AZD1613 - Part A

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

Placebo - Part A

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

AZD1613 - Part B

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

Placebo - Part B

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

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days) ]
  • Change From Baseline in Safety 12-Lead ECG QTcF [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Safety 12-Lead ECG PR Interval [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Safety 12-Lead ECG QRS Duration [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Heart Rate (12-Lead Safety ECG) [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in ALT [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in AST [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Total Bilirubin [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Serum Creatinine [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Estimated Glomerular Filtration Rate (eGFR; CKD-EPI 2021) [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in INR [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Prothrombin Time (PT) [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Activated Partial Thromboplastin Time (aPTT) [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) [ Time Frame: Baseline (Day -1) and scheduled visits through Day 189 ±3 days; UACR as triplicate first-morning voids per visit ]
  • Change From Baseline in Systolic Blood Pressure [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Diastolic Blood Pressure [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Heart Rate (Vital Signs) [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Body Temperature [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Respiratory Rate [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]
  • Change From Baseline in Oxygen Saturation (SpO2) [ Time Frame: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Jacksonville, Florida, United States, 32216

Research Site

Recruiting

Orlando, Florida, United States, 32808

Research Site

Recruiting

Lenexa, Kansas, United States, 66219

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

AstraZeneca

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-28.