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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and nature of injection site reaction
Timeframe: 7 days after administration of the investigational products
2
Frequency and nature of systemic reactions
Timeframe: 7 days after administration of the investigational products
3
Frequency and nature of Serious Adverse Events
Timeframe: 72 Weeks after administration of the investigational products
4
Evaluation of the pain experienced by the participant
Timeframe: Immediately after EP, 5 minutes after EP and 10 minutes after EP
5
Evaluation of laboratory related adverse events
Timeframe: Up to 7 days after administration of the investigational product
6
Serum concentration of dMAb AZD5396 nm/mL.
Timeframe: Up to 72 Weeks after administration of the investigational products
. 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.
Timeframe: Up to 72 Weeks after administration of the investigational products