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ElectroPoration In a Clinical Setting (EPIC)

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ClinicalTrials.gov Identifier: NCT04698694
Recruitment Status : Completed
First Posted : January 7, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Rottapharm
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:
This is a single-blind, single-center, randomized, study in healthy subjects in which the volunteer patients will remain blind with respect to the voltage strength received.

Condition or disease Intervention/treatment Phase
Tolerance Device: Electroporation with voltage amplitude of 40 V (corresponding to an electric field strength of 100 V/cm) Device: Electroporation with voltage amplitude of 60 V (corresponding to an electric field strength of 150 V/cm) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Twenty (20) subjects will be randomized 1:1 to one of the following EP conditions:

  1. voltage amplitude of 40 V (10 subjects)
  2. voltage amplitude of 60 V (10 subjects).
Masking: Double (Participant, Investigator)
Masking Description: The subjects and investigators will remain blind with respect to the voltage strength received.
Primary Purpose: Treatment
Official Title: Tolerability of Intramuscular Electroporation Delivery by Cliniporator® in Healthy Volunteers
Actual Study Start Date : December 9, 2020
Actual Primary Completion Date : December 14, 2020
Actual Study Completion Date : December 21, 2020

Arm Intervention/treatment
Experimental: Subjects treated with Cliniporator® using a voltage amplitude of 40 V
10 subjects deemed eligible are between 18-55 y of age respected the inclusion and exclusion criteria will be selected in a randomized way (1:1) and treated with a voltage amplitude of 40 V.
Device: Electroporation with voltage amplitude of 40 V (corresponding to an electric field strength of 100 V/cm)
The physician will select the voltage amplitude of 40 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.

Experimental: Subjects treated with Cliniporator® using a voltage amplitude of 60 V
10 subjects deemed eligible are between 18-55 y of age respected the inclusion and exclusion criteria will be selected in a randomized way (1:1) and treated with a voltage amplitude of 60 V.
Device: Electroporation with voltage amplitude of 60 V (corresponding to an electric field strength of 150 V/cm)
The physician will select the voltage amplitude of 60 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.




Primary Outcome Measures :
  1. Pain of intramuscular delivery of a sterile solution followed by electroporation [ Time Frame: approximately 1 month ]
    Subjsects will rate the intramuscolar pain using the Visual Analog Scale (VAS) to rate the level of pain experienced from the minimum value of "No Pain" and the maximum value "Pain as bad as it could possibly be".

  2. Discomfort level of intramuscular delivery of a sterile solution followed by electroporation [ Time Frame: approximately 1 month ]
    Subjsects will rate discomfort level using an 11-point Numerical Rating Scale (NRS). Scores range from the minimum value 0 that means ''None'' to 10 that means ''Severe''.

  3. Pain of intramuscular delivery of a sterile solution followed by electroporation [ Time Frame: approximately 1 month ]
    Subjsects will rate the Perseption of Injection (PIN) questionnaire. Scores range from the minimum value 1 that means ''None'' to 5 that means ''very very much''.


Secondary Outcome Measures :
  1. Incidence of Injection site Adverse Events [ Time Frame: approximately 1 month ]
    Number of AE at the injection site

  2. Incidence of sistemic Adverse Events [ Time Frame: approximately 1 month ]
    Number of sistemic AE



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Ages Eligible for Study:   18 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent obtained before undergoing any study-specific procedure
  2. Healthy subjects, as determined by a responsible physician, based on a medical evaluation including medical history and physical examination
  3. Males or females aged ≥18 and ≤ 55 years
  4. A minimum weight of 50 kg and Body Mass Index >18.5 and ≤30 kg/m2
  5. Vital signs within the following values or ranges:

    1. Body temperature ≤ 37,5 °C
    2. Pulse frequency ≥51 and ≤100 beats per minute
    3. Diastolic BP ≥60 mmHg, ≤ 90 mmHg
    4. Systolic BP ≥ 90 mmHg, ≤ 140 mmHg
  6. Normal ECG
  7. CPK within normal reference range
  8. Non-pregnant women of childbearing potential, non-breastfeeding
  9. Able and willing to comply with all study procedures.

Exclusion Criteria:

  1. Any past or present cardiac disease, even if not evident at ECG
  2. Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor deficiency) or prior history of significant bleeding or bruising following IM injections or venepuncture
  3. History of seizures or mental illness
  4. Metal implants within 20 cm of the planned site(s) of injection
  5. Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
  6. Any abnormality or permanent body art (e.g. tattoos) that would interfere with the ability to observe local reactions at the injection site in the deltoid area
  7. History of alcohol or drug abuse during the 12 months preceding the screening
  8. Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
  9. Breastfeeding
  10. Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.

Information from the National Library of Medicine

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): NCT04698694


Locations
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Italy
ASST Monza-Ospedale San Gerardo
Monza, Italy
Sponsors and Collaborators
University of Milano Bicocca
Rottapharm
Publications:
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04698694    
Other Study ID Numbers: EPIC trial
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
coronavirus infection
vaccine
intramuscular electroporation