Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA® 2000 (Electroporation, EP)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Seongnam, Korea, Republic of
- Seoul National University Bundang Hospital
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 19-70 years;
- Able to provide consent to participate and having signed an Informed Consent Form (ICF);
- Able and willing to comply with all study procedures;
- Women of child-bearing potential agree to either remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile during this trials , or have a partner who is medically unable to induce pregnancy.
- Normal screening ECG or screening ECG with no clinically significant findings;
- Screening laboratory must be within normal limits or have only Grade 0-1 findings;
- No history of clinically significant immunosuppressive or autoimmune disease.
- Not currently or within the previous 4 weeks taking immunosuppressive agents (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than or equal to 10 mg/day or steroid equivalent).
Exclusion Criteria:
- Administration of an investigational compound either currently or within 90 days of first dose;
- Previous receipt of an investigational product for the treatment or prevention of MERS-CoV or SARS-CoV except if subject is verified to have received placebo;
- Previous infection with MERS-CoV;
- Administration of any vaccine within 4 weeks of first dose;
- Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose
- Administration of any blood product within 3 months of first dose;
- Pregnancy or breast feeding or plans to become pregnant during the course of the study;
- History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
- Positive serologic test for HIV, Hepatitis B surface antigen, or hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
- Baseline evidence of kidney disease as measured by creatinine greater than 1.5mg/dL (CKD Stage II or greater);
- Baseline screening lab(s) with Grade 2 or higher abnormality;
- Chronic liver disease or cirrhosis;
- Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
- Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose greater than 10 mg/day or steroid equivalent);
- Past (within 6 months), current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept, or other monoclonal antibody;
- Prior major surgery or any radiation therapy within 4 weeks of group assignment;
- Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome; history of PSVT syndrome, history of prolonged QT syndrome;
- Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD);
- Metal implants within 20 cm of the planned site(s) of injection;
- Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection.
- Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints;
- Not willing to allow storage and future use of samples for MERS-CoV related research
- Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
- Presence of tattoos covering all possible injection sites.
- Healthcare workers participating in the medical examination of patients infection with MER
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: GLS-5300 with ID Cellectra electroporation
GLS-5300 at 0.3mg DNA/dose
|
[Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)
GLS-5300 administered ID followed by Cellectra 2000 Electroporation
|
|
EXPERIMENTAL: GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation
GLS-5300 at 0.3mg DNA/dose
|
[Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)
GLS-5300 administered ID followed by Cellectra 2000 Electroporation
|
|
EXPERIMENTAL: GLS-5300 at 0.6mg DNA/dose (3 dose regimen)
GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
|
[Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)
GLS-5300 administered ID followed by Cellectra 2000 Electroporation
|
|
EXPERIMENTAL: GLS-5300 at 0.6mg DNA/dose (2 dose regimen)
GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation
|
[Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)
GLS-5300 administered ID followed by Cellectra 2000 Electroporation
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of adverse events
Time Frame: Day0 through up to 60 weeks
|
Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule
|
Day0 through up to 60 weeks
|
|
Administration (injection) site reactions
Time Frame: Day0 through up to 60 weeks
|
Administration (injection) site reactions described by frequency
|
Day0 through up to 60 weeks
|
|
Changes in safety laboratory parameters
Time Frame: Day0 through up to 60 weeks
|
Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.
|
Day0 through up to 60 weeks
|
|
Administration (injection) site pain
Time Frame: Administration (injection) site pain
|
Administration (injection) site pain as described by Visual Analog Scale (VAS)
|
Administration (injection) site pain
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cellular Immune Responses
Time Frame: Day0 through up to 60 weeks
|
Antigen specific cellular immune responses to MERS-CoV as determined by Interferon-gamma (IFN-γ) ELISpot
|
Day0 through up to 60 weeks
|
|
Binding antibody titers
Time Frame: Day0 through up to 60 weeks
|
Binding antibody titers against MERS-CoV for a 2 and 3 dose vaccination regimens
|
Day0 through up to 60 weeks
|
|
Neutralizing antibodies
Time Frame: Day0 through up to 60 weeks
|
Titers of neutralizing antibodies against MERS-CoV
|
Day0 through up to 60 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Joel Maslow, MD, PhD, MBA, GeneOne Life Science, Inc.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- MERS-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.