dMAbs for COVID-19 Prevention

Overseen By Pablo Tebas, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pablo Tebas

Must not be taking: Blood thinners, TNF-α inhibitors

Disqualifiers: Diabetes, Hypertension, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

61 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take certain medications like blood thinners or immunosuppressive therapies. It's best to discuss your specific medications with the study team.

What is the purpose of this trial?

This trial tests a new way to deliver disease-fighting proteins using DNA instructions and an electric pulse. It targets healthy adults to ensure safety and tolerability. The treatment helps the body produce its own antibodies by injecting DNA into muscle cells. This technique significantly improves gene expression compared to simple DNA injection.

Research Team

Pablo Tebas, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

Healthy adults aged 18-60 with a BMI of 20-30, normal ECG and lab results, willing to use contraception if fertile. Excludes those with SARS-CoV-2 infection, recent antibody treatments or vaccines, pregnancy, certain infections like hepatitis B/C, immunosuppressive conditions or medications, major surgery within the last 6 months, metal implants at EP site.

Inclusion Criteria

Normal screening ECG or screening ECG with no clinically-significant findings

My recent lab results are mostly normal.

For Cohort H: Participants in a prior cohort who received their first dose at least 52 weeks prior to Cohort H Day 0 dose

Exclusion Criteria

Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD)

I have chronic liver disease or cirrhosis.

Baseline screening lab with Grade 2 or higher abnormality, except for Grade 2 creatinine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dMAb AZD5396 and dMAb AZD8076 with Hylenex® delivered intramuscularly followed by electroporation in a 2-dose or 4-dose regimen

4 weeks

4 visits (in-person) for 4-dose regimen, 2 visits (in-person) for 2-dose regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

Treatment Details

Interventions

• dMAb AZD5396
• dMAb AZD8076

Trial Overview The trial is testing two dMAbs (AZD5396 and AZD8076) for COVID-19 prevention in healthy adults. Participants will receive intramuscular injections followed by electroporation using CELLECTRA devices on Days 0 and 3. The study aims to assess safety and how the body processes these antibodies.

Participant Groups

Group I: Cohort G - 4x 0.5 mg Experimental Treatment 5 Interventions

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.

Group II: Cohort F - 2x 0.5 mg Experimental Treatment 4 Interventions

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.

Group III: Cohort E - 2x 2 mg Experimental Treatment 4 Interventions

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.

Group IV: Cohort D - 2x 0.25 mg Experimental Treatment 4 Interventions

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.

Group V: Cohort C - 2x 1 mg Experimental Treatment 4 Interventions

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.

Group VI: Cohort B - 2x 0.5 mg Experimental Treatment 4 Interventions

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.

Group VII: Cohort A2 - 1x 1 mg Experimental Treatment 4 Interventions

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.

Group VIII: Cohort A1 - 1x 0.5 mg Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Pablo Tebas

Lead Sponsor

Trials

1

Recruited

60+

The Wistar Institute

Collaborator

Trials

10

Recruited

790+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Inovio Pharmaceuticals

Industry Sponsor

Trials

54

Recruited

4,800+