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Clinical Trial Details

Trial ID: L0055
Source ID: NCT03126318
Associated Drug: Cor-001
Title: A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001
Acronym: COR-001-SC1
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: COR-001|DRUG: Placebo
Outcome Measures: Primary: The safety of a 5 mg dose of COR-001 as measured by the incidence of adverse events, To evaluate the safety of a 5 mg dose of COR-001 delivered subcutaneously, 1 month after the 4th patient has received study drug|The safety of a 15 mg dose of COR-001 as measured by the incidence of adverse events, To evaluate the safety of a 15 mg dose of COR-001 delivered subcutaneously, 1 month after the 4th patient has received study drug|The safety of a 50 mg dose of COR-001 as measured by the incidence of adverse events, To evaluate the safety of a 50 mg dose of COR-001 delivered subcutaneously, 1 month after the 4th patient has received study drug|The safety of a 100 mg dose of COR-001 as measured by the incidence of adverse events, To evaluate the safety of a 100 mg dose of COR-001 delivered subcutaneously, 1 month after the 4th patient has received study drug | Secondary: Pharmacokinetic analysis: maximum serum drug concentrations (Cmax), To evaluate single-dose pharmacokinetics of COR-001 delivered subcutaneously, Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.|Pharmacokinetic analysis: area under the serum drug concentration-time curve (AUC), To evaluate the single-dose pharmacokinetics of COR-001 delivered subcutaneously, Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.|Pharmacokinetic analysis: terminal elimination half-life (t1/2), To evaluate the single-dose pharmacokinetics of COR-001 delivered subcutaneously, Pre-dose, 4 hours post-dose, and days 2-7, 11, 15, 22, 29, 57, 85, 141, and 225 post-dose.|The effectiveness of COR-001 as measured by levels of an inflammatory marker, To evaluate the effectiveness of COR-001 as measured by CRP levels., Screening and at weeks 1 - 5, 8, 12, 20, and 32.
Sponsor/Collaborators: Sponsor: University of Colorado, Denver | Collaborators: Corvidia Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-05-19
Completion Date: 2019-12-19
Results First Posted:
Last Update Posted: 2020-09-09
Locations: University of Coloardo Anschutz Medical Campus, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT03126318