Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2022-05-19
2025-11-21
Brief Summary
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The hypothesis is that the administration of dMAb AZD5396 and dMAb AZD8076 will be safe and associated with expression of mAb AZD5396 and mAb AZD8076 in serum.
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Detailed Description
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If one dose limiting toxicity (DLT) is observed in the first three participants enrolled in any cohort, an ad hoc DSMB will review the event and make a decision if the study should continue. If the DSMB agrees that the study should continue, the remaining participants will be enrolled in the cohort and dosed, but the next cohort will not open until the 28-day period of safety is completed. However, if any additional DLT occurs (i.e., \>1 DLT in 6 total participants in a given cohort), then that dose will be deemed not tolerated
The following Investigational product administration- and/or EP-related adverse events are defined as DLTs:
* Grade 3 or greater local injection site erythema, swelling, and/or induration recorded ≥ 1 hour after Investigational product administration
* Pain or tenderness at the injection site that requires overnight hospitalization despite proper use of non-narcotic analgesics.
* Grade 3 or greater systemic symptoms assessed by the Principal Investigator as related to Investigational product administration.
* Grade 3 or greater clinically significant laboratory abnormalities assessed by the Principal Investigator as related to Investigational product administration.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Cohort A1 - 1x 0.5 mg
Participants (n=3) will be administered 0.5 mg of dMAb AZD5396 and 0.5 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0, for a total dose of 0.5 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Cohort A2 - 1x 1 mg
Participants (n=3) will be administered 1 mg of dMAb AZD5396 and 1 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0, for a total dose of 1 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Cohort B - 2x 0.5 mg
Participants (n=6) will be administered 0.5 mg of dMAb AZD5396 and 0.5 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0 and D3, for a total dose of 1 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Cohort C - 2x 1 mg
Participants (n=6) will be administered 1mg of dMAb AZD5396 and 1 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0 and D3, for a total dose of 2 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Cohort D - 2x 0.25 mg
Participants (n=6) will be administered 1 mg of dMAb AZD5396 and 1 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0 and D3, for a total dose of 2 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Cohort E - 2x 2 mg
Participants (n=5) will be administered 2 mg of dMAb AZD5396 and 2 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0 and D3, for a total dose of 4 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Cohort F - 2x 0.5 mg
Participants (n=5) will be administered 0.5 mg of dMAb AZD5396 and 0.5 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0070 parameter on D0 and D3, for a total dose of 1 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0070 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Cohort G - 4x 0.5 mg
Participants (n=5) will be administered 0.5 mg of dMAb AZD5396 and 0.5 mg of dMAb AZD8076 with Hylenex® delivered intramuscularly using the side port needle followed by electroporation (EP) with OpBlock 0078 parameter on D0, D3, D28 and D31, for a total dose of 2 mg of each plasmid.
dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
Interventions
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dMAb AZD5396
Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
dMAb AZD8076
Participants will receive one injection of dMAb AZD8076 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Hylenex
Hylenex® recombinant will be used for dMAb AZD5396 and dMAb AZD8076 dose preparation at the clinical site.
CELLECTRA™ 2000 with Side Port needle, OpBlock 0070 Electroporation device
The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.
Eligibility Criteria
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Inclusion Criteria
2. Able to provide consent to participate and having signed an Informed Consent Form (ICF).
3. Able and willing to comply with all study procedures.
4. Body mass index (BMI) between 20 and 31, inclusive.
5. Screening laboratory must be within normal limits or have only Grade 0-1 findings.
6. Normal screening ECG or screening ECG with no clinically-significant findings.
7. Women of child-bearing potential agree to one of the following:
1. use medically effective contraception (oral contraception, barrier methods, spermicide, etc.)
2. have a partner who is sterile from enrollment to 6 months following the last injection
3. have a partner who is medically unable to induce pregnancy Abstinence is acceptable per Investigator discretion and as long as it is documented that the subject will use medically effective contraception when engaging in sexual activities and notifies the study team.
8. Sexually active men who are considered sexually fertile must agree to one of the following:
1. use a barrier method of contraception during the study and continue its use for at least 6 months following the last injection
2. have a partner who is permanently sterile or is medically unable to become pregnant
9. No history of clinically significant immunosuppressive or autoimmune disease. Individuals with HIV infection who have been virologically suppressed for more than 1 year and with current CD4 cell count entry greater than 500 cells/ul will be allowed into the study.
Exclusion Criteria
2. Administration of any vaccine within 4 weeks of first dose.
3. Administration of a SARS-CoV-2 vaccine in the last 14 days or plans to have any standard of care vaccines within 14 days form the last administration of study products.
4. Positive SARS-CoV-2 infection at screening visit.
5. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose.
6. Administration of any blood product within 3 months of first dose.
7. Co-morbid conditions including poorly-controlled diabetes (HbA1C \> 7), poorly-controlled hypertension (BP \> 140/95 repeatedly), asthma, and any cardiovascular disease.
8. Pregnancy or breast feeding or plans to become pregnant during the course of the study.
9. Positive serologic test for hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Director.
10. Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
11. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL (CKD Stage II or greater);
12. Baseline screening lab with Grade 2 or higher abnormality, except for Grade 2 creatinine.
13. Chronic liver disease or cirrhosis.
14. Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation.
15. Current or anticipated concomitant immunosuppressive therapy (inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or prednisone at a dose less than 10 mg/day or steroid dose-equivalent are not exclusionary).
16. Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept.
17. Prior major surgery or any radiation therapy within 6 months of first dose.
18. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome.
19. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD)
20. Fewer than two acceptable sites available for IM injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
1. Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site.
2. Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist).
3. Any metal implants or implantable medical device within the electroporation site.
21. Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness.
22. 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.
23. Not willing to allow storage and future use of samples for SARS-CoV-2 virus related research.
24. Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
25. Participants with known bleeding diatheses or that are using blood thinners for 30 days before study enrollment including warfarin, heparin, Clopidogrel, Apixaban (Eliquis), Dabigatran (Pradaxa), Edoxaban (Savaysa), Rivaroxaban (Xarelto). The use of low dose aspirin (81 mg daily) is acceptable.
26. Participants with concomitant intramuscular medications.
18 Years
60 Years
ALL
Yes
Sponsors
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The Wistar Institute
OTHER
AstraZeneca
INDUSTRY
Inovio Pharmaceuticals
INDUSTRY
Pablo Tebas
OTHER
Responsible Party
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Pablo Tebas
Professor of Medicine. University of Pennsylvania
Principal Investigators
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Pablo Tebas, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Tebas P, Patel A, Agnes JT, Parzych EM, Baer A, Caturla M, Ghosh S, Purwar M, Bedanova N, Tsang C, Morales K, Amante D, Fisher PD, Francica JR, Humeau L, Kulp DW, Pallesen J, Leon P, Esser M, Smith TRF, Weiner DB. Safety and pharmacokinetics of SARS-CoV-2 DNA-encoded monoclonal antibodies in healthy adults: a phase 1 trial. Nat Med. 2025 Dec;31(12):4150-4159. doi: 10.1038/s41591-025-03969-0. Epub 2025 Oct 21.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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850355
Identifier Type: -
Identifier Source: org_study_id
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