A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From randomization (Day 1) through end of follow-up (up to Day 189 ±3 days)
Change From Baseline in Safety 12-Lead ECG QTcF
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Safety 12-Lead ECG PR Interval
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Safety 12-Lead ECG QRS Duration
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Heart Rate (12-Lead Safety ECG)
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in ALT
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in AST
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
AstraZeneca Clinical Study Information Center
Change From Baseline in Total Bilirubin
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Serum Creatinine
Timeframe: 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)
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in INR
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Prothrombin Time (PT)
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR)
Timeframe: 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
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Diastolic Blood Pressure
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Heart Rate (Vital Signs)
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Body Temperature
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Respiratory Rate
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days
Change From Baseline in Oxygen Saturation (SpO2)
Timeframe: Baseline (Day -1) and post-dose at scheduled visits through Day 189 ±3 days