dMAbs for Prevention of COVID-19

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This is a Phase 1, open-label, single center, dose escalation study to evaluate the safety, tolerability and pharmacokinetic profile of mAb AZD5396 and mAb AZD8076 following delivery of optimized dMAb AZD5396 and dMAb AZD8076 with Hylenex® Recombinant, administered by intramuscular injection (IM) followed immediately by electroporation (EP) using the CELLECTRA™ 2000 with Side Port needle device, in a 2-dose regimen (Days 0 and 3) or a 4-dose regimen (Days 0, 3, 28 and 31) in healthy adults. 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.

Key facts

Study ID

NCT05293249

Run by

Pablo Tebas

People needed

61

Starts

2022-05-19

Expected to finish

2025-11-21

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-60 years.
• Able to provide consent to participate and having signed an Informed Consent Form (ICF).
• Able and willing to comply with all study procedures.
• Body mass index (BMI) between 20 and 31, inclusive.
• Screening laboratory must be within normal limits or have only Grade 0-1 findings.
• Normal screening ECG or screening ECG with no clinically-significant findings.
• Women of child-bearing potential agree to one of the following:
• use medically effective contraception (oral contraception, barrier methods, spermicide, etc.)
• have a partner who is sterile from enrollment to 6 months following the last injection
• 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.
• Sexually active men who are considered sexually fertile must agree to one of the following:
• use a barrier method of contraception during the study and continue its use for at least 6 months following the last injection
• have a partner who is permanently sterile or is medically unable to become pregnant
• 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.

You may not qualify if…

• Administration of an investigational compound either currently or within 6 months of first dose.
• Administration of any vaccine within 4 weeks of first dose.
• 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.
• Positive SARS-CoV-2 infection at screening visit.
• 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.
• Co-morbid conditions including poorly-controlled diabetes (HbA1C > 7), poorly-controlled hypertension (BP > 140/95 repeatedly), asthma, and any cardiovascular disease.
• Pregnancy or breast feeding or plans to become pregnant during the course of the study.
• Positive serologic test for hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Director.
• Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
• Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL (CKD Stage II or greater);
• Baseline screening lab with Grade 2 or higher abnormality, except for Grade 2 creatinine.
• Chronic liver disease or cirrhosis.
• Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation.
• 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).
• Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept.
• Prior major surgery or any radiation therapy within 6 months of first dose.
• Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome.
• Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD)
• Fewer than two acceptable sites available for IM injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
• Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site.
• 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).
• Any metal implants or implantable medical device within the electroporation site.
• Prisoner or participants 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.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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