AstraZeneca
A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).
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.
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 ant…
Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.
Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT.
Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT.