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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants have suitable veins for cannulation or repeated venipuncture
Healthy male or female participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, days 15, 31, 91, 181, and day 365
Awards & highlights
Study Summary
This trial tests the safety and how a drug is absorbed and distributed in the body of healthy adult men and women.
Who is the study for?
Healthy adults who test negative for COVID-19, weigh between 45-110 kg with a BMI of 18-32. They must have good veins for injections and commit to follow-up for up to a year. Excluded are those with recent immunoglobulins or blood products, pregnant or non-abstinent women without contraception, abnormal lab values, recent SARS-CoV-2 infection, hypersensitivity to AZD3152 or EVUSHELD mAb therapy.Check my eligibility
What is being tested?
The study tests the safety and body's handling (pharmacokinetics) of AZD3152 at various doses and administration methods (intramuscular injection and intravenous infusion) in healthy participants against a placebo control.See study design
What are the potential side effects?
Potential side effects aren't detailed but may include reactions related to immune response due to the nature of monoclonal antibodies like AZD3152. Participants will be monitored for any adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My veins can be used for repeated needle insertions.
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I am a healthy individual.
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My weight is between 45 and 110 kg, and my BMI is between 18 and 32.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose, days 15, 31, 91, 181, and day 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, days 15, 31, 91, 181, and day 365
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent total body clearance (CL/F) of AZD3152 (IM administration only)
Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)
Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152
+11 moreSecondary outcome measures
Number of participants with anti-drug antibody (ADA) to AZD3152
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD3152 Dose Z (IV)Experimental Treatment1 Intervention
Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion.
Group II: AZD3152 Dose Y (IV)Experimental Treatment1 Intervention
Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion.
Group III: AZD3152 Dose Y (IM)Experimental Treatment1 Intervention
Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections.
Group IV: AZD3152 Dose X (IV)Experimental Treatment1 Intervention
Participants will receive dose X of AZD3152 on Day 1 as an IV infusion.
Group V: AZD3152 Dose X (IM)Experimental Treatment1 Intervention
Participants will receive dose X of AZD3152 on Day 1 as a single IM injection.
Group VI: Pooled placeboPlacebo Group1 Intervention
Participant will receive placebo on Day 1 either via IM injection or IV infusion.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,804 Total Patients Enrolled
52 Trials studying COVID-19
256,197,425 Patients Enrolled for COVID-19
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a weak immune system or am taking medication that weakens my immune system.I have a history of a significant health condition.My veins can be used for repeated needle insertions.I am a healthy individual.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I use effective birth control or practice abstinence.You had COVID-19 within the last month before the first visit to the study.My weight is between 45 and 110 kg, and my BMI is between 18 and 32.I haven't had any serious illnesses or surgeries in the last 4 weeks.You need to have a negative COVID-19 test result before the first visit.I received an EVUSHELD shot within the last 15 months.You had a bad reaction after getting a certain type of medication before.I do not have HIV or hepatitis B or C.I haven't received any immunoglobulin or blood products in the last 6 months.Your lab test results are not within the normal range as specified in the study guidelines.You have a known allergy to AZD3152.I received a COVID-19 vaccine within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: AZD3152 Dose Y (IV)
- Group 2: Pooled placebo
- Group 3: AZD3152 Dose X (IM)
- Group 4: AZD3152 Dose X (IV)
- Group 5: AZD3152 Dose Y (IM)
- Group 6: AZD3152 Dose Z (IV)
Awards:
This trial has 0 awards, including: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.
Are elderly individuals over the age of 75 excluded from participating in this clinical research?
"The age range for this trial is restricted to participants who are at least 18 years old and not yet 55."
Answered by AI
Does my profile fit the criteria for participation in this research?
"This clinical trial is open to participants aged 18-55 with a confirmed Covid diagnosis. A maximum of 48 patients will be accepted into the study."
Answered by AI
Is it safe to administer AZD3152 Dose X (IM) to individuals?
"While limited data exists regarding the safety and efficacy of AZD3152 Dose X (IM), our team at Power assessed its risk on a scale from 1 to 3, awarding it a score of 1."
Answered by AI
Is enrollment in this clinical trial available to the public?
"Based on the available data, this trial is no longer in need of participants. Originally posted on June 5th 2023 and last updated on May 15th 2023, it has since concluded its recruitment process. However, at present there are 883 other trials actively seeking out volunteers for their studies."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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