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Healthy volunteers test new antibody delivery method

NCT ID NCT05293249

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety and how the body handles two experimental antibodies (AZD5396 and AZD8076) in 61 healthy adults. Participants received the antibodies through injections followed by a mild electrical pulse to help the body produce them. The goal was to check for side effects and measure antibody levels in the blood, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

61 people

The number who actually took part.

Started

May 2022

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Age 18-60 years. 2. Able to provide consent to participate and having signed an Informed Consent Form (ICF). 3. Able and willing to comply with all study procedures. 4. Body mass index (BMI) between 20 and 31, inclusive. 5. Screening laboratory must be within normal limits or have only Grade 0-1 findings. 6. Normal screening ECG or screening ECG with no clinically-significant findings. 7. Women of child-bearing potential agree to one of the following: 1. use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) 2. have a partner who is sterile from enrollment to 6 months following the last injection 3. 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. 8. Sexually active men who are considered sexually fertile must agree to one of the following: 1. use a barrier method of contraception during the study and continue its use for at least 6 months following the last injection 2. have a partner who is permanently sterile or is medically unable to become pregnant 9. 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 1. Administration of an investigational compound either currently or within 6 months of first dose. 2. Administration of any vaccine within 4 weeks of first dose. 3. 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. 4. Positive SARS-CoV-2 infection at screening visit. 5. Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose. 6. Administration of any blood product within 3 months of first dose. 7. Co-morbid conditions including poorly-controlled diabetes (HbA1C \> 7), poorly-controlled hypertension (BP \> 140/95 repeatedly), asthma, and any cardiovascular disease. 8. Pregnancy or breast feeding or plans to become pregnant during the course of the study. 9. Positive serologic test for hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Director. 10. Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response); 11. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL (CKD Stage II or greater); 12. Baseline screening lab with Grade 2 or higher abnormality, except for Grade 2 creatinine. 13. Chronic liver disease or cirrhosis. 14. Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation. 15. 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). 16. Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept. 17. Prior major surgery or any radiation therapy within 6 months of first dose. 18. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome. 19. Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator (AICD) 20. Fewer than two acceptable sites available for IM injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: 1. Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site. 2. 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). 3. Any metal implants or implantable medical device within the electroporation site. 21. Prisoner or participants who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness. 22. 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. 23. Not willing to allow storage and future use of samples for SARS-CoV-2 virus related research. 24. 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. 25. 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. 26. Participants with concomitant intramuscular medications.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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