Status:
ACTIVE_NOT_RECRUITING
dMAbs for Prevention of COVID-19
Lead Sponsor:
Pablo Tebas
Collaborating Sponsors:
The Wistar Institute
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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...
Detailed Description
The study will apply a single ascending dose (SAD) modified 3+3 design. Participants will be enrolled sequentially beginning with Cohort A1. The first participant in cohort A1 will be dosed on Day 0. ...
Eligibility Criteria
Inclusion
- 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:
- 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.
- Exclusion Criteria
- 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.
- Not willing to allow storage and future use of samples for SARS-CoV-2 virus related research.
- 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.
- 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.
- Participants with concomitant intramuscular medications.
Exclusion
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05293249
Start Date
May 19 2022
End Date
December 1 2025
Last Update
October 16 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104