dMAbs for Prevention of COVID-19 (NCT05293249) | Clinical Trial Compass
CompletedPhase 1
dMAbs for Prevention of COVID-19
United States61 participantsStarted 2022-05-19
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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:
✕. 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.