A Study Evaluating the Safety and Efficacy of Neuroprotective Peptide CN-105 Peptide in Patients With Acute Supratentorial Intracerebral Hemorrhage

NCT ID: NCT06255977

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-24
• Study Completion Date: 2024-08-31

Brief Summary

Intracerebral hemorrhage (ICH) is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes. Apolipoprotein E (apoE) has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory responses. We developed a 5-amino acid peptide, CN-105, that mimics the polar face of the apoE helical domain involved in receptor interactions, readily crosses the blood-brain barrier, and improves outcomes in well-established preclinical ICH models. In the current study, aim to assess the safety and the efficacy of CN-105 after administration for three consecutive days in participants with acute supratentorial ICH at three different dosages.

Detailed Description

Inclusion Patients with spontaneous acute supratentorial intracerebral hemorrhage confirmed by CT，age 30 to 80 years，Intravenous infusion with CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours。

Blood samples for protein markers will be collected and detected at screening, 48 h(D3), and 120 h(D6) after the first dose:

The sample size is 240.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Control: placebo

Intravenous infusion with placebo（same volume of saline） every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of placebo（same volume of saline） will be administered as a slow IV bolus over 30 minutes.

Group Type: PLACEBO_COMPARATOR

CN-105

Intervention Type: DRUG

Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Experimental: CN-105 peptide for injection 0.1 mg/kg

Intravenous infusion with 0.1 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Group Type: EXPERIMENTAL

CN-105

Intervention Type: DRUG

Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Experimental:CN-105 peptide for injection 0.3 mg/kg

Intravenous infusion with 0.3 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Group Type: EXPERIMENTAL

CN-105

Intervention Type: DRUG

Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Experimental: CN-105 peptide for injection 1.0 mg/kg

Intravenous infusion with 1.0 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Group Type: EXPERIMENTAL

CN-105

Intervention Type: DRUG

Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Interventions

CN-105

Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Intervention Type: DRUG

Other Intervention Names

CN-105peptide

Eligibility Criteria

Inclusion Criteria

1. Is male or female, age 30 to 80 years, inclusive;

2. Has a confirmed diagnosis of spontaneous supratentorial ICH by CT;

3. Able to receive first dose of study drug ≤ 12 hours after onset of ICH symptoms, such as alteration in level of consciousness, severe headache, nausea, vomiting, seizure, and/or focal neurological deficits, or last-known well time;

4. Has a GCS score ≥ 8 at enrollment;

5. Has an NIHSS score ≥ 6

6. Has Systolic BP (SBP) < 200 mmHg

7. Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR).

Exclusion Criteria

1. Is pregnant or lactating;

2. Has a temperature greater than 38.5℃ at Screening;

3. The amount of intracerebral hemorrhage< 5 mL（ coniglobus formula）

4. ICH known to result from trauma;

5. Primary intraventricular hemorrhage；

6. Radiographic evidence of underlying brain tumor;

7. Patients with a history of malignant tumor (non-melanoma in situ skin cancer that has achieved complete remission after treatment and has not relapsed in the past 5 years or other types eligible for inclusion in the opinion of the investigator);

8. Known unstable mass or active radiographic evidence and symptoms of herniation severely limiting the recovery potential of the patient in the opinion of the investigator;

9. Known ruptured cerebral aneurysm, arteriovenous malformation, or vascular anomaly; hemorrhage from cerebral infarction, cerebral venous sinus embolization;

10. Has a platelet count < 100×109/L，(INR) > 1.5 or irreversible coagulopathy either due to medical condition or detected before screening;

11. Is taking new oral anticoagulants (such as dabigatran etexilate, rivaroxaban, apixaban, etc.) or low molecular weight heparin at the time of ICH onset;

12. In the opinion of the investigator is unstable and would benefit from supportive care rather than supportive care plus CN-105;

13. In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI;

14. Severe renal insufficiency: creatinine clearance <30 mL/ min (Cockcroft-Gault formula), urea nitrogen and/or serum creatinine >1.5×ULN;

15. Is scheduled for surgical intervention throughout the trial period dose, including but not limited to hematoma evacuation (including minimally invasive and routine surgery), decompressive craniectomy, hematoma aspiration；

16. Clinically significant history of cardiovascular disease, including; (1) congestive heart failure (NYHA Class > 2); (2) unstable angina; (3) myocardial infarction in the past 12 months; (4) any need for treatment or interventional supraventricular arrhythmia or ventricular arrhythmia;

17. Has electrocardiogram (ECG) examination abnormalities deemed clinically significant by the investigator: for example, QTc interval prolongation during screening (male > 450 ms, female > 470 ms) (Note: QTc interval must be calculated according to Fridericia's criteria);

18. Subjects were disabled before disease onset (mRS ≥ 2)

19. Patients with past intracranial hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, or cerebral infarction/transient ischemic attack (TIA, but excluding lucunar infarction);

20. Patients have other serious/severe acute or chronic mental illnesses, including recent (within the past 1 year) or current suicidal ideations or behaviors;

21. May increase the risks associated with participating in research or study drug management, or may interfere with the results of the study, or may interfere with the investigator's interpretation of laboratory abnormalities;

22. Patients are employees of the research center or family members directly related to the participants of this study, or subordinates who are not directly related to the trial but are subordinates of the trial, or are employed by the sponsor directly related to the trial;

23. Is predisposed to allergy or known allergy to any ingredient in the study drug;

24. Patients who have participated in other clinical trials or are participating in another interventional clinical study within 3 months prior to enrollment;

25. For other reasons, the investigator considered the subjects are inappropriate to be enrolled in the trial.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SDM Bio Service Inc.

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

shuya Li, Study Director

Role: STUDY_DIRECTOR

IRB of Beijing Tiantan Hospital,Capital Medical University

Locations

Beijing Tiantan Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

yongjun Wang, Study Director

Role: CONTACT

yongjunwang111@aliyun.com

13911172565

shuya Li, Study Director

Role: CONTACT

shuyali85@163.com

13601367028

Facility Contacts

yongjun Wang

Role: primary

yongjunwang111@aliyun.com

13911172565

Other Identifiers

PR-CBT-2019040-2F

Identifier Type: -

Identifier Source: org_study_id