A Phase I Randomised, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1613 Following Multiple Ascending Dose Administration in Participants With Autosomal Dominant Polycystic Kidney Disease
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Research Site
NOT_YET_RECRUITING
Birmingham
California
Research Site
NOT_YET_RECRUITING
Loma Linda
Florida
Research Site
NOT_YET_RECRUITING
Jacksonville
Research Site
RECRUITING
Orlando
Kansas
Research Site
RECRUITING
Lenexa
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
Minnesota
Research Site
NOT_YET_RECRUITING
Rochester
Texas
Research Site
NOT_YET_RECRUITING
San Antonio
Other Locations
China
Research Site
NOT_YET_RECRUITING
Chengdu
Research Site
NOT_YET_RECRUITING
Hangzhou
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
NOT_YET_RECRUITING
Wuhan
Research Site
NOT_YET_RECRUITING
Xiamen
United Kingdom
Research Site
NOT_YET_RECRUITING
London
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2027-01-04
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca