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AzTrials

Healthy VolunteersPhase 1NCT05293249

dMAbs for Prevention of COVID-19

A Phase 1 study testing dMAb AZD5396, dMAb AZD8076 and CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device in people with Healthy Volunteers, run by Pablo Tebas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
dMAb AZD5396, dMAb AZD8076 and CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
19 May 2022to 21 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Single Center, Dose Escalation Study of the Safety and Pharmacokinetics of mAb AZD5396 and mAb AZD8076 Delivered as dMAbs in Healthy Adults

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.

Read the 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. If no stopping event (DLT) is observed after 14 days of the initial dose, the remaining two participants in that cohort will be dosed. If there are 0 DLT events after 14 days of the initial dosing of the third subject, enrollment will be completed, and then cohort A2 will open. Same process will be followed for Cohorts B, C and E. Because cohorts D, F \& G are a similar or lower dose and the safety profile would have been already established in previous cohorts, the 14-day waiting periods will not apply to Cohorts D, F or G.

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.
Being tested
dMAb AZD5396, dMAb AZD8076, CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device, Hylenex, CELLECTRA™ 2000 with Side Port needle, OpBlock 0070 Electroporation device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dMAb AZD5396Combination product

    Participants will receive one injection of dMAb AZD5396 with Hylenex into the arm (deltoid)/leg (quadriceps) region followed by EP.

  • dMAb AZD8076Combination product

    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 deviceCombination product

    The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.

  • HylenexDrug

    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 deviceCombination product

    The device will be used to perform electroporation (EP) on each subject immediately after being dosed with dMAb AZD5396 and dMAb AZD8076.

Study groups in NCT05293249
Study groupRoleWhat they receive
Cohort A1 - 1x 0.5 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex
Cohort A2 - 1x 1 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex
Cohort B - 2x 0.5 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex
Cohort C - 2x 1 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex
Cohort D - 2x 0.25 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex
Cohort E - 2x 2 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex
Cohort F - 2x 0.5 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Drug: Hylenex; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0070 Electroporation device
Cohort G - 4x 0.5 mgExperimentalParticipants (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.
Receives: Combination Product: dMAb AZD5396; Combination Product: dMAb AZD8076; Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device; Drug: Hylenex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and nature of injection site reaction

    Injection site reactions occurring up to 7 days after administration of the investigational product

    Measured: 7 days after administration of the investigational products

  2. Frequency and nature of systemic reactions

    Systemic reactions occurring up to 7 days after administration of the investigational product.

    Measured: 7 days after administration of the investigational products

  3. Frequency and nature of Serious Adverse Events

    SAE will be classified using the CTCAE v5 throughout the study

    Measured: 72 Weeks after administration of the investigational products

  4. Evaluation of the pain experienced by the participant

    Visual analogue scale (VAS). A VAS consists of a horizontal line, 10 cm in length, anchored by word descriptors at each end (no pain = 0 cm; worst pain = 10 cm). The VAS score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks. Absolute initial value and change over time will be described.

    Measured: Immediately after EP, 5 minutes after EP and 10 minutes after EP

  5. Evaluation of laboratory related adverse events

    Laboratory AEs will be assessed and graded in accordance with the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials", issued in September 2007.

    Measured: Up to 7 days after administration of the investigational product

  6. Serum concentration of dMAb AZD5396 nm/mL.

    The number and percentage of participants in which detection of monoclonal antibody dMAb AZD5396 in serum is achieved will be summarized with a point estimate and corresponding exact 90% Clopper- Pearson confidence interval. These will be summarized per time point within each cohort. We will also estimate the time to 50% decline from peak concentration.

    Measured: Up to 72 Weeks after administration of the investigational products

  7. Serum concentration of dMAb AZD8076 nm/mL.

    The number and percentage of participants in which detection of monoclonal antibody dMAb AZD8076 in serum is achieved will be summarized with a point estimate and corresponding exact 90% Clopper- Pearson confidence interval. These will be summarized per time point within each cohort. We will also estimate the time to 50% decline from peak concentration.

    Measured: Up to 72 Weeks after administration of the investigational products

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start19 May 2022
  3. Primary completion11 Jun 2025
  4. Study completion21 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05293249
Sponsor's protocol ID
850355
Status last verified
Jan 2026
First submitted
4 Mar 2022
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 41120767

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dMAb AZD5396, dMAb AZD8076 and CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device in people with Healthy Volunteers, run by Pablo Tebas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and nature of injection site reaction (time frame: 7 days after administration of the investigational products). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05293249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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