Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-17 @ 6:43 PM
Study NCT ID:
NCT02248051
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury
Sponsor:
Complexa, Inc.
Organization:
Study Overview
Official Title:
An Open-Label, Non-Randomized Study of Safety, Tolerability and Pharmacokinetics of Intravenous CXA-10 Emulsion in Subjects With Stage 3 and 4 Chronic Kidney Injury
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
Detailed Description:
This will be a multi-center, open-label study, single-dose study with CXA-10 in subjects with CKI. At total of 12 subjects will be enrolled into two equal groups according to their baseline estimated glomerular filtration rate (eGFR: 15 - 39 or 40 - 59 mL/min/1.73m2). All subjects will receive a single dose infusion of CXA-10 emulsion. Since this is the first administration of CXA-10 to a non-healthy volunteer population, a conservative approach is being taken to ensure safety. Thus, the first 2 subjects from each group will be dosed at one dose level below the highest safe dose level administered in the FIH study. If this dose is found to be safe in this specific subject population, the remainder of the 4 subjects in each group will receive the highest safe dose from the FIH study; otherwise, the remainder will receive the initial dose. The doses administered in this study will not exceed the highest exposures achieved in the FIH study, and doses may need to be adjusted to lower levels, based on further evaluation of current pharmacokinetic data, to ensure the appropriate the exposure level. Safety, PK and PD assessments will be conducted over approximately 18 days following each dosing session. There will be a follow-up visit approximately 1 week after dosing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: