Overview

Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Complexa, Inc.
Treatments:
CXA-10
Criteria
Inclusion Criteria:

1. Male or female subjects of non-child bearing potential 18 to 70 years of age
(inclusive).

2. Moderate to severe CKI (equivalent to National Kidney Foundation Kidney Disease
Outcomes Quality Initiative [NKF KDOQI] Stage 3 or 4, not receiving dialysis) as
determined by estimated glomerular filtration rate (eGFR) greater than or equal to 15
and less than 60 mL/min/1.73 m2 (according to the creatinine-cystatin C equation)
within less than or equal to 3 months prior to the screening visit. Cause of the CKI
should be recorded where possible.

3. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive)

4. Subjects must have resting heart rates (HR) greater than or equal to 50 beats per
minute at baseline

5. QTcF interval (Fredericia's correction factor) of the baseline ECG must be less than
or equal to 450 msec for males and less than or equal to 470 msec for females at
screening and predose. Subjects with any other clinically relevant ECG parameter
abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG
abnormality will be excluded from the study. Subjects with a history of congenital
long QT syndrome or short QT syndrome in the subject or in the subject's family will
be excluded from the study.

6. Adequate bilateral venous access to allow for dose infusions and blood sampling

7. Ability to comprehend and comply with procedures

8. Agree to commit to participate in the current protocol

9. Provide written informed consent prior to any study procedure being performed

Exclusion Criteria:

1. Female subjects who are pregnant or lactating or who are trying to conceive

2. Female subjects with a positive serum β-human chorionic gonadotropin (β-hCG) test at
screening or Day -1 for any dosing day

3. History of renal transplantation

4. History of acute dialysis or acute kidney injury within 12 wks prior to screening and
dosing

5. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 3.0X upper
limit of normal (ULN), gamma-glutamyl transferase (GGT) greater than 3X ULN, and total
bilirubin greater than 2X ULN. If all liver function tests (LFTs) are within normal
limits (WNL) and total bilirubin is elevated, examination of direct and indirect
bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are
presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are WNL.

6. Presence of signs and symptoms of uremia

7. Past history of pancreatitis

8. History of documented hypersensitivity reaction to eggs or egg products (as the
vehicle contains egg phospholipids)

9. History of documented hypersensitivity reaction to soy or soy products (as vehicle
contains soy bean oil)

10. Uncontrolled diabetes with HbA1c > 9 percent or subjects with frequent hypoglycemic
attacks

11. Active cardiovascular disease within 12 weeks of dosing, including unstable angina,
myocardial infarction, coronary artery bypass or percutaneous transluminal
angioplasty/stent, cerebrovascular accident including transient ischemic attack, any
history of syncope, dizziness, cardiac arrhythmias, cardiac arrest, pacemakers,
cardioversion, and clinical diagnosis of severe obstructive valvular heart disease or
severe hypertrophic cardiomyopathy

12. Current diagnosis of Class 3 or 4 New York Heart Association (NYHA) congestive heart
failure.

13. Uncontrolled hypertension with sitting blood pressure greater than 160 mmHg systolic
and or greater than 100 mmHg diastolic after 5 minutes rest (feet on floor, arm held
at level of heart) at the screening visit

14. Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes
rest (as above) at the screening visit

15. Any abnormalities on 12-lead ECG, as deemed by the investigator and/or medical
monitor, at screening

16. Any clinically significant murmurs evident on auscultation of the heart (including
evidence of mitral valve prolapse)

17. History of smoking or use of nicotine-containing products in excess of approximately a
pack per day (estimated at 20 cigarettes per day) or equivalent within the past 2
weeks

18. History of drug abuse or dependence within 6 months of the study

19. History of regular alcohol consumption within 6 months of the study, defined as an
average weekly intake of >21 units for males or >14 units for females. One unit is
equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125
mL) of wine or 1 measure (25 mL) of spirits.

20. A positive drug screen for drugs of abuse, including alcohol at the screening visit or
at entry to the clinic

21. Treatment with any investigational drug within 30 days or 5 half-lives prior to the
beginning of the screening period (this includes investigational formulations of
marketed products, inhaled and topical drugs)

22. Blood collection of greater than 500 mL within 56 days prior to screening

23. Seropositive for human immunodeficiency virus (HIV) at screening

24. Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus
antibody (HCV Ab) at screening

25. Any other condition and/or situation that causes the Investigator to deem a subject
unsuitable for the study (e.g., due to expected study medication non compliance,
inability to medically tolerate the study procedures, or a subject's unwillingness to
comply with study related procedures)