Evidence map›Paper›PMID 27990643›Full record

Trial reportJournal of clinical pharmacology2017

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Escalating Dose and Repeated Doses of CN-105 in Healthy Adult Subjects.

Jeffrey T Guptill, Shruti M Raja, Felix Boakye-Agyeman, Robert Noveck, Sarah Ramey, Tian Ming Tu, Daniel T Laskowitz

2 registry-linked trialsAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03168581 phase2completednot on this map

A Proof of Concept Study to Evaluate Administration of CN-105 in Patients With Acute Supratentorial Intracerebral Hemorrhage

TypeinterventionalSponsorAegisCN LLCRan2017 to 2020Enrolled38ConditionsIntracerebral HemorrhageArmsCN-105
NCT03711903 phase2completednot on this mapstarted 2019, after this paper: background citation

A Phase 2, Randomized, Double Blind, Placebo , Controlled Study To Evaluate The Administration of CN-105 In Participants With Acute Supratentorial Intracerebral Hemorrhage

TypeinterventionalSponsorNational Neuroscience InstituteRan2019 to 2022Enrolled60ConditionsIntracerebral HemorrhageArmsAcetyl-Valine-Serine-Arginine-Arginine-Arginine-NH2 (Ac-VSRRR- NH2)., 0.9% Sodium-chloride
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. APOE-Targeted Therapeutics for Alzheimer's Disease.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2025
    Review
  7. Article
  8. Article
  9. ApoE Mimetic Peptides as Therapy for Traumatic Brain Injury.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Jeffrey T GuptillDepartment of Neurology, Duke University, Durham, NC, USA.
Shruti M RajaDepartment of Neurology, Duke University, Durham, NC, USA.
Felix Boakye-AgyemanDuke Clinical Research Institute, Durham, NC, USA.
Robert NoveckDuke Clinical Research Institute, Durham, NC, USA.
Sarah RameyDuke Clinical Research Institute, Durham, NC, USA.
Tian Ming TuSingHealth, National Neuroscience Institute, Singapore, Republic of Singapore.
Daniel T LaskowitzDepartment of Neurology, Duke University, Durham, NC, USA.
Clinical Research Institute · USDuke University · USNational Neuroscience Institute · SG

Funding

Immunological biomarker studies in myasthenia gravisK23NS085049 · NINDS · DUKE UNIVERSITY · PI GUPTILL, JEFFREY T · 2014 to 2018
$924k
NINDS NIH HHS K23 NS085049
6 · The paper itself

Abstract

Spontaneous intracranial hemorrhage (ICH) remains a devastating stroke subtype, affecting as many as 80,000 people annually in the United States and associated with extremely high mortality. In the absence of any pharmacological interventions demonstrated to improve outcome, care for patients with ICH remains largely supportive. Thus, despite advances in the understanding of ICH and brain injury, there remains an unmet need for interventions that improve neurologic recovery and outcomes. Recent research suggesting inflammation and APOE genotype play a role in modifying neurologic outcome after brain injury has led to the development of an APOE-derived peptide agent (CN-105). Preclinical studies have demonstrated that CN-105 effectively downregulates the inflammatory response in acute brain injury, including ICH. Following Investigational New Drug (IND) enabling studies in murine models, this first-in-human single escalating dose and multiple dose placebo-controlled clinical trial was performed to define the safety and pharmacokinetics (PK) of CN-105. A total of 48 subjects (12 control, 36 active) were randomized in this study; all subjects completed the study. No significant safety issues were identified with both dosing regimens, and PK analysis revealed linearity without significant drug accumulation. The median half-life in the terminal elimination phase of CN-105 following a single or repeated dosing regimen did not change (approximately 3.6 hours). With the PK and preliminary safety of CN-105 established, the drug is now poised to begin first-in-disease phase 2 clinical trials in patients with ICH who urgently need new therapeutic options.

Indexed as

AdultAnti-Inflammatory AgentsDouble-Blind MethodFemaleHealthy VolunteersHumansMaleNeuroprotective AgentsAnti-Inflammatory AgentsNeuroprotective Agentsapolipoprotein Ebrain injuryintracerebral hemorrhageneuroinflammationneuroprotectionpharmacokinetics

Identifiers

PMID27990643
PMCPMC5524215
OpenAlexW2563311768

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.