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Monoclonal Antibodies
dMAbs for COVID-19 Prevention
Phase 1
Recruiting
Led By Pablo Tebas, MD
Research Sponsored by Pablo Tebas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Screening laboratory must be within normal limits or have only Grade 0-1 findings
No history of clinically significant immunosuppressive or autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after ep, 5 minutes after ep and 10 minutes after ep
Awards & highlights
Study Summary
This trial is testing whether a new method of delivering two antibodies is safe. The hypothesis is that the new delivery method will be safe and associated with the expression of the antibodies in serum.
Who is the study for?
Healthy adults aged 18-60 with a BMI of 20-30, normal ECG and lab results, willing to use contraception if fertile. Excludes those with SARS-CoV-2 infection, recent antibody treatments or vaccines, pregnancy, certain infections like hepatitis B/C, immunosuppressive conditions or medications, major surgery within the last 6 months, metal implants at EP site.Check my eligibility
What is being tested?
The trial is testing two dMAbs (AZD5396 and AZD8076) for COVID-19 prevention in healthy adults. Participants will receive intramuscular injections followed by electroporation using CELLECTRA devices on Days 0 and 3. The study aims to assess safety and how the body processes these antibodies.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, general discomfort like fatigue or headaches due to immune response from dMAb administration. Electroporation might cause temporary skin irritation or muscle twitching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent lab results are mostly normal.
Select...
I do not have a history of serious immune system diseases.
Select...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after ep, 5 minutes after ep and 10 minutes after ep
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after ep, 5 minutes after ep and 10 minutes after ep
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of laboratory related adverse events
Evaluation of the pain experienced by the participant
Frequency and nature of Serious Adverse Events
+4 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Cohort H - 2x 1 mgExperimental Treatment4 Interventions
Participants (n=5) 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 more than 52 weeks after prior administration, for a total dose of 2 mg of each plasmid.
Group II: Cohort G - 4x 0.5 mgExperimental Treatment5 Interventions
Participants (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.
Group III: Cohort F - 2x 0.5 mgExperimental Treatment4 Interventions
Participants (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.
Group IV: Cohort E - 2x 2 mgExperimental Treatment4 Interventions
Participants (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.
Group V: Cohort D - 2x 0.25 mgExperimental Treatment4 Interventions
Participants (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.
Group VI: Cohort C - 2x 1 mgExperimental Treatment4 Interventions
Participants (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.
Group VII: Cohort B - 2x 0.5 mgExperimental Treatment4 Interventions
Participants (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.
Group VIII: Cohort A2 - 1x 1 mgExperimental Treatment4 Interventions
Participants (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.
Group IX: Cohort A1 - 1x 0.5 mgExperimental Treatment4 Interventions
Participants (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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hylenex
2016
Completed Phase 4
~60
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Pablo TebasLead Sponsor
The Wistar InstituteOTHER
8 Previous Clinical Trials
694 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,275 Previous Clinical Trials
288,613,551 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic liver disease or cirrhosis.You have no clinically significant findings on an ECG or a screening ECG.My creatinine level is above 1.5 mg/dL, indicating kidney issues.My recent lab results are mostly normal.I have not received any vaccines in the last 4 weeks.I have diabetes, high blood pressure, asthma, or heart disease that is not well-managed.I haven't had a COVID-19 vaccine or plan to get any vaccine within 2 weeks of the last study product dose.I have a bleeding disorder or have been on blood thinners within the last 30 days.I do not have a history of serious immune system diseases.I am currently on or expect to start immunosuppressive therapy.I am currently taking medication via injections into my muscles.I am between 18 and 60 years old.I haven't received any blood products in the last 3 months.I haven't had major surgery or radiation therapy in the last 6 months.I have less than two suitable spots for muscle injections.I have tattoos or scars near where the treatment will be given.I am a sexually active man and will use contraception or my partner is unable to become pregnant.I have HIV, but it's been under control for over a year with a CD4 count above 500.I have had hepatitis C but was successfully treated.I haven't received any antibody treatments in the last 4 weeks.I have a condition that weakens my immune system, like a blood cancer or a history of organ transplant.I am currently or planning to be treated with TNF-alpha inhibitors.I am between 18 and 60 years old.My recent lab results are mostly normal.You are able to provide consent to participate and you have signed an Informed Consent Form (ICF).Your body mass index (BMI) falls between 20 and 30, which is considered a healthy range.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort G - 4x 0.5 mg
- Group 2: Cohort E - 2x 2 mg
- Group 3: Cohort F - 2x 0.5 mg
- Group 4: Cohort H - 2x 1 mg
- Group 5: Cohort D - 2x 0.25 mg
- Group 6: Cohort A1 - 1x 0.5 mg
- Group 7: Cohort A2 - 1x 1 mg
- Group 8: Cohort B - 2x 0.5 mg
- Group 9: Cohort C - 2x 1 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of participant is ideal for this clinical experiment?
"This trial is recruiting 24 healthy individuals that meet the following criteria: age between 18 and 60, BMI of 20-30, normal laboratory results with a Grade 0-1 findings at most, uneventful ECG readings or no clinically significant findings, women of childbearing potential must use contraception while sexually active men are expected to do the same for 6 months after their last injection. Also those without immunosuppressive history and HIV positive participants who have been virologically suppressed for over one year with current CD4 cell count greater than 500 cells/ul may be accepted as well."
Answered by AI
What is the current sample size of this clinical trial?
"Affirmative. Clinicaltrials.gov records that this medical trial, initially posted on May 19th 2022, is presently admitting participants. 24 volunteers are needed from a single clinical setting for the study to move forward."
Answered by AI
Is the age limit for eligibility in this medical trial limited to 40 or below?
"This medical trial requires participants to be aged between 18 and 60. 50 trials accommodate underage individuals while 372 are open for seniors over 65 years old."
Answered by AI
What is the safety profile of dMAb AZD8076 for those taking part in research?
"Due to the lack of data regarding its safety and efficacy, dMAb AZD8076 was awarded a score of 1 on Power's scale."
Answered by AI
Are there any open spots in this clinical investigation?
"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical investigation, initially posted on May 19th 2022, is currently searching for eligible participants. 24 individuals must be recruited from a single location."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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