Southeastern Clinical Research Institute, LLC | Augusta, GA
Status and phase
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About
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Full description
This is a randomized, double-blind, placebo-controlled multiple ascending dose and an open-label fixed-dose Phase 1b study consisting of two parts, Part A and Part B. In Part A, multiple ascending doses of RGLS8429 or placebo will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429. In Part B, a fixed-dose of RGLS8429 will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
70 participants in 3 patient groups
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Central trial contact
Kristen Gillotti
Data sourced from clinicaltrials.gov
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