Acute Kidney Injury (Nontraumatic)Phase 1NCT02127190
Study of CXA-10 in Healthy Volunteers
A Phase 1 study testing CXA-10 emulsion in people with Acute Kidney Injury (Nontraumatic), run by Complexa, Inc. at 1 site in United States.
Trial summary
This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion vehicle infusion in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- What is being tested?
- CXA-10 emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects and female subjects of non-child bearing potential between the ages of 18 and 50 years (inclusive)
- Females must not be of child bearing potential (defined as bilateral oophorectomy, hysterectomy, or post-menopausal [amenorrhea for minimum of 1 year and post-menopausal status confirmed by follicle stimulating hormone (FSH) testing]). Female subjects unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal) must have this documented in the case report form (CRF).
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 kg and 100 kg (inclusive)-Part A and B only
- BMI between 30 and 50 kg/m2 for subjects in Part C only
- In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis. Subjects in Part C only may be allowed to have blood pressure readings up to160/100.
- Subjects must have resting heart rates (HR) ≥50 beats per minute at baseline
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- QTcF interval (Fredericia's correction factor) of the baseline ECG must be ≤430 msec for males and ≤450 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 in the subject or in the subject's family will be excluded from the study (see Section 6.4.3.
- Adequate bilateral venous access to allow for repeated dose infusions and blood sampling
- Ability to comprehend and comply with procedures
- Agree to commit to participate in the current protocol
- Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
Who cannot join
- Female subjects who are pregnant or lactating or who are trying to conceive
- Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening and Day -1 for any dosing day
- Any clinically relevant abnormality identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
- Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes
- History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
- Past history of pancreatitis
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- History of documented hypersensitivity reaction to eggs or egg products (as vehicle contains egg phospholipids)
- History of documented hypersensitivity reaction to soy or soy products (as vehicle contains soy bean oil)
- History of regular alcohol consumption exceeding 14 units/week for women or 21 units/week for men (one unit = 125 mL of wine or 284 mL of beer or a single 25 mL measure of spirits) within 6 months of screening
- History of smoking or use of nicotine-containing products within the past 6 months
- Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements) within seven days or five half-lives, whichever is longer, prior to dosing and until collection of the final PK sample. Use of any drug including aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) must be avoided within 7 days prior to the first dose and during this study as it will interfere with the pharmacology of CXA-10. Use of high energy supplements or drinks (especially, those containing caffeine, protein supplements, and weight loss drugs) and smoking cessation products (gum, inhalers, patches) will be prohibited.
- -Only acetaminophen will be permitted at doses of -2 grams/day
- Sitting blood pressure >140 mmHg systolic and/or >90 mmHg diastolic after 5 minutes rest (feet on floor, arm held at level of heart) at the screening visit for subjects who participate in Parts A and B. Subjects in Part C only may be allowed to have blood pressure readings up to 160 mmHg systolic and up to 100 mmHg diastolic
- Resting heart rate ≥100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
- Any abnormalities on 12-lead ECG at screening including, but not limited to any of the following
- PR interval >200 msec or <120 msec
- Non-specific intra-ventricular conduction delay (IVCD) with QRS duration ≥110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB)
- Incomplete RBBB as defined by QRS duration ≥100 msec but <120 msec with RBBB pattern
- Complete RBBB and LBBB
- Evidence of second- or third- degree AV block
- Pathological Q-waves (Q-wave wider than 0.04 sec or depth greater than 0.4-0.5 mV)
- Evidence of ventricular pre-excitation
- Evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities, LBBB and/or RBBB
- QTcF interval of the baseline ECG ≥430 msec for males and ≥450 msec for females at screening and at predose of the first dosing session, and any other clinically relevant ECG parameter (e.g., PR interval, QRS deviation) or abnormality
- Any cardiac murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)
- A positive urine drug screen for drugs of abuse, including alcohol or positive urine cotinine (≥300 ng/mL for cotinine) at the screening visit or at entry to the clinic (Note: urine cotinine required at screening visit only).
- Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
- Blood collection of greater than 500 mL within 56 days prior to screening
- Seropositive for human immunodeficiency virus (HIV) at screening
- Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Jasper Clinical Research & Development, Inc.
Kalamazoo, Michigan, 49007
About this study
Official title: A Randomized, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled 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 CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Being tested
- CXA-10 emulsion, Placebo
- Keywords
- nitro-fatty acids, anti-inflammatory, Nrf2 activation, contrast induced AKI
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXA-10 emulsionDrug
CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CXA-10 placebo emulsion | Placebo comparator | single intravenous dose of CXA 10 placebo emulsion Receives: Drug: Placebo |
| CXA-10 Emulsion | Experimental | single ascending intravenous doses of CXA-10 emulsion Receives: Drug: CXA-10 emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Serious and Non-Serious Adverse Events
Measured: First day of dosing through 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James VanderLugt, MD, Principal investigator, Jasper Clinic, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127190
- Sponsor's protocol ID
- CXA-10-001
- Status last verified
- May 2016
- First submitted
- 24 Mar 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Third Party Open (Sponsor), Dose-Rising, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of CXA-10 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02127190
- Acronym / sponsor ID
- CXA-10-001
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- nitro-fatty acids, anti-inflammatory, Nrf2 activation, contrast induced AKI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Complexa, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be the first-in-human (FIH) study with CXA-10. The main purpose of this trial is to demonstrate the tolerability, safety and pharmacokinetics (PK) of CXA-10 at various incremental doses, and to demonstrate the safety and tolerability of the rate of the emulsion vehicle infusion in healthy volunteers. In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXA-10 placebo emulsion | Placebo comparator | Drug: Placebosingle intravenous dose of CXA 10 placebo emulsion |
| CXA-10 Emulsion | Experimental | Drug: CXA-10 emulsionsingle ascending intravenous doses of CXA-10 emulsion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male subjects and female subjects of non-child bearing potential between the ages of 18 and 50 years (inclusive)
- Females must not be of child bearing potential (defined as bilateral oophorectomy, hysterectomy, or post-menopausal [amenorrhea for minimum of 1 year and post-menopausal status confirmed by follicle stimulating hormone (FSH) testing]). Female subjects unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal) must have this documented in the case report form (CRF).
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and a weight between 60 kg and 100 kg (inclusive)-Part A and B only
- BMI between 30 and 50 kg/m2 for subjects in Part C only
- In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis. Subjects in Part C only may be allowed to have blood pressure readings up to160/100.
Key exclusion criteria (31 listed)
- Female subjects who are pregnant or lactating or who are trying to conceive
- Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening and Day -1 for any dosing day
- Any clinically relevant abnormality identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
- Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes
- History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CXA-10 emulsionCXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion. | Drug | CXA-10 Emulsion |
| Placebo | Drug | CXA-10 placebo emulsion |
Primary outcome
Number of subjects with Serious and Non-Serious Adverse Events
Time frame: First day of dosing through 30 days after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James VanderLugt, MD principal investigator
Jasper Clinic, Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CXA-10 emulsion in people with Acute Kidney Injury (Nontraumatic), run by Complexa, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Serious and Non-Serious Adverse Events (time frame: First day of dosing through 30 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.