Status:
COMPLETED
ElectroPoration In a Clinical Setting
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
Rottapharm
Conditions:
Tolerance
Eligibility:
All Genders
18-55 years
Phase:
NA
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.
Detailed Description
Background: The major obstacle to the preventive or therapeutic success of DNA vaccines is undoubtedly their delivery. If this cannot be made simple, cheap and effective, they may not become a viable...
Eligibility Criteria
Inclusion
- Signed and dated informed consent obtained before undergoing any study-specific procedure
- Healthy subjects, as determined by a responsible physician, based on a medical evaluation including medical history and physical examination
- Males or females aged ≥18 and ≤ 55 years
- A minimum weight of 50 kg and Body Mass Index \>18.5 and ≤30 kg/m2
- Vital signs within the following values or ranges:
- Body temperature ≤ 37,5 °C
- Pulse frequency ≥51 and ≤100 beats per minute
- Diastolic BP ≥60 mmHg, ≤ 90 mmHg
- Systolic BP ≥ 90 mmHg, ≤ 140 mmHg
- Normal ECG
- CPK within normal reference range
- Non-pregnant women of childbearing potential, non-breastfeeding
- Able and willing to comply with all study procedures.
Exclusion
- Any past or present cardiac disease, even if not evident at ECG
- 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
- History of seizures or mental illness
- Metal implants within 20 cm of the planned site(s) of injection
- Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
- 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
- History of alcohol or drug abuse during the 12 months preceding the screening
- Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
- Breastfeeding
- 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.
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04698694
Start Date
December 9 2020
End Date
December 21 2020
Last Update
April 21 2021
Active Locations (1)
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1
ASST Monza-Ospedale San Gerardo
Monza, Italy