A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19. (NCT07445971) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
United States80 participantsStarted 2026-03-24
Plain-language summary
This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 administered by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes in healthy adults and adults at higher risk for severe COVID-19. Participants will receive single IV, IM, and SC doses of MDX2301 or placebo and a repeat IM or SC dose approximately 3 months apart of MDX2301 or placebo.
Who can participate
Age range
18 Years – 64 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
. Participant is a healthy male or female, 18 to 64 years of age.
. Participant is in good health in the opinion of the investigator.
. Participant is a male or female, 18 to 64 years of age.
. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors:
. Asthma
. Diabetes
. Cerebrovascular disease, which affects blood flow to the brain.
. Chronic kidney disease
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
Adverse Events
Timeframe: Baseline until end of study, up to approximately 12 months
. Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug.
. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening.
. Participant has any serious disease, condition, or disorder that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug or interpretation of study results, or may lead to hospitalization or death within the study period.
. Participant has evidence of active hepatitis B or hepatitis C infections at screening.
. Participant has abnormal vital signs, ECG findings, or laboratory values at Screening or Day -1.
. Participant tests positive for SARS-CoV-2 infection at screening.
. Participant self-reports having COVID-19 or received COVID-19 antiviral for prophylaxis or treatment prior to Day 1.
. Participant has received a SARS-CoV-2 vaccine prior to dosing.