Chronic Kidney Injury Clinical Trial
Official title:
A Two-Part, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled and Open-Label Exploratory Food Effect Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of CXA-10 in Healthy Volunteers
This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part B).
This will be the first-in-human (FIH) study with oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as single ascending oral doses to healthy volunteers (Part A). The effects of food on the PK of CXA-10 will also be investigated (Part B). Part A of the study will be a single-center, randomized, double-blind, third party open (sponsor) placebo-controlled study. Sequential single ascending doses will be administered in up to 5 cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state, as illustrated in the table below. Part B of the study will be a single-center, open-label, two-period study conducted in two cohorts of subjects as follows. The selected dose and the interval between Period 1 and Period 2 will be determined based on emerging PK data from Part A. The selected dose will be an intermediate dose level to avoid a food effect interaction that markedly enhances exposure. Subjects who participate in Part B of the study will receive two doses of CXA-10. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05328986 -
Kidney Disease After COVID-19
|