At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD1613 - Part A (drug), Placebo - Part A (drug), AZD1613 - Part B (drug), Placebo - Part B (drug)
- How long the study runs
- Study runs about 18 months (dates as stated)
- About the drug or intervention
- AZD1613 - Part A — drug: Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. · Placebo - Part A — drug: Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT. · AZD1613 - Part B — drug: Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. · Placebo - Part B — drug: Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 40
- Started
- 2025-11-10
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for autosomal dominant polycystic kidney disease
- • Phase1 - 40 participants
- • A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD)
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with autosomal dominant polycystic kidney disease
Where?
- • London - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
More detail
This Phase I, randomised, single-blind, placebo-controlled study will assess the safety and tolerability of AZD1613 and characterise the pharmacokinetics (PK) of AZD1613 in participants with autosomal dominant polycystic kidney disease (ADPKD), following subcutaneous (SC) or intravenous (IV) administration. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD1613. Furthermore, the safety and PK profile will be evaluated in Chinese participants with ADPKD to assess any potential race effect in this population.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results...
- ✓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
Who cannot take part
- ✗As judged by the investigator, any evidence of heart, vascular, and other kidney conditions which in the...
- ✗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...
See the full criteria
Where Is This Study? (1 UK site)
Research Site
London NW3 2QG, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
