Safety Study of CN-105 Neuroprotective Peptide for Intracerebral Hemorrhage
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|ClinicalTrials.gov Identifier: NCT02670824|
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage (ICH)||Drug: CN-105 Drug: Placebo||Phase 1|
Intracerebral hemorrhage (ICH), which is often associated with longstanding hypertension, affects as many as 50,000 people annually in the United States alone. ICH remains associated with poor outcome, and approximately 40 to 50% of afflicted patients will die within 30 days. Unfortunately, little improvement has been made in the ICH-associated mortality rate over the last 20 years. To address this issue, the National Institutes of Health issued a priorities report in 2005, and the American Heart Association released a recent set of clinical guidelines for the first time in nearly a decade. In these reports, the importance of developing clinically relevant models of ICH that will extend our understanding of the pathophysiology of the disease and target new therapeutic approaches was emphasized. At present, however, there are no proven neuroprotective pharmacological treatments for ICH or other forms of acute brain injuries, such as traumatic brain injury (TBI) and subarachnoid hemorrhage (SAH).
To meet this unmet medical need, CereNova, LLC has developed a novel therapeutic approach based on the known biological function of endogenous apolipoprotein E (apoE), a key mediator of the neuroinflammatory response and recovery from a variety of acute and chronic brain injuries1-5. There are three common human isoforms of apolipoprotein E, designated apoE2, apoE3, and apoE4, which differ by single cysteine to arginine substitutions at positions 112 and 158. Although originally defined in the context of cholesterol metabolism, apoE is also produced in the brain, where it modulates neuroinflammatory responses and functional outcomes after injury in an isoform specific fashion1. Specifically, the apoE3 protein isoform plays an adaptive role in downregulating glial activation and reducing secondary neuronal injury, whereas the E4 isoform is associated with increased neuroinflammation and poor functional outcomes.
Although the intact apoE holoprotein does not cross the blood brain barrier (BBB) and thus cannot be administered therapeutically, we have previously demonstrated that smaller apoE mimetic peptides do effectively cross the BBB while effectively downregulating the brain inflammatory responses in vitro and in vivo6. CN-105, CereNova's lead clinical candidate, is a small, 5 amino acid apoE-mimetic peptide that is derived from the receptor binding region of apoE. CN-105 retains the anti-inflammatory and neuroprotective effects of intact apoE, is well tolerated in preclinical studies, and readily crosses the BBB to effectively reduce inflammatory responses in the brain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Escalating Dose and Repeated Doses of CN-105 in Healthy Adult Subjects|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||August 2016|
Experimental: CN-105 Active Drug
The CN-105 drug administered via IV at an escalating scale of mg/kg.
A1-0.01 mg/kg A2-0.03 mg/kg A3-0.1 mg/kg A4-0.3 mg/kg A5-1.0 mg/kg B1-1.0 mg/kg
Single and multiple intravenous (IV) doses of CN-105
Placebo Comparator: Placebo
- The number and percentage of participants having study procedure-related suspected adverse reactions assessed by change from baseline in vital signs, ECG and clinical labs. [ Time Frame: up to 1 week ]The number and percentage of participants having study procedure-related suspected adverse reactions assessed by change from baseline in vital signs, ECG and clinical labs will be tabulated and evaluated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670824
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27705|