NCT07445971 · ModeX Therapeutics, An OPKO Health Company
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
What this study is about
This first-in-human study is designed to evaluate the safety, tolerability, how the drug moves through the body, anti-drug antibodies, and neutralizing activity of MDX2301 administered by given through a vein (IV) (IV), intramuscular (IM), or injected under the skin (SC) routes in healthy adults and adults at higher risk for severe COVID-19.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Healthy Adults
- Participant is a healthy male or female, 18 to 64 years of age.
- Participant is in good health in the opinion of the investigator. Adults at Higher Risk for Developing Severe COVID-19:
- 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:
- Cerebrovascular disease, which affects blood flow to the brain.
- Chronic kidney disease
- Chronic lung disease
- Cardiac disease
- Chronic liver disease
- Cystic fibrosis
- HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening.
- Sickle cell disease or thalassemia
- Participant is clinically stable with no clinically significant abnormalities.
- Participant has not been hospitalized within the 12 months prior to screening or is not expected to be hospitalized during the study due to underlying medical conditions. All Participants
- Female participants of childbearing potential must have a negative urine pregnancy test.
- Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method.
- Participant is able to understand and sign the informed consent form prior to undergoing any study procedures.
- Participant is willing and able to comply with scheduled visits and procedures.
Exclusion criteria
- Healthy Adults
- 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. Adults at Higher Risk for Severe COVID-19:
- 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. All Participants
- 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.
- Participant has received a monoclonal antibody (mAb) for SARS-CoV-2 or convalescent plasma for SARS-CoV-2 prior to Day 1.
- Participant has received or is expected to receive for the duration of the study immunoglobulin, blood-derived products, high-dose systemic corticosteroids, or other immunosuppressant drugs within 6 months prior to Day 1.
- Participant is pregnant, breastfeeding, or seeking pregnancy while on the study.
- Participant with a known clinically significant bleeding disorder that would prohibit the participant from receiving an IV infusion or IM or SC injection.
- Participant had major surgery within 30 days prior to Day 1.
- Participant has donated blood prior to screening.
- Participant has any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.
- Participant has a history of alcoholism or illicit drug use prior to screening or a positive test for drugs of abuse at screening or on Day -1.
- Participant is a current smoker or user of other nicotine containing products on a daily basis.
- Participant has received an investigational product within 30 days prior to Day 1.
- Participant has a known hypersensitivity to any components of MDX2301, any of its excipients or closely related compounds. For All Participants, Temporary Exclusions for Randomization on Day 1 if Remains within the Screening Window:
- Participant has any acute illness, within 3 days of Day 1.
- Participant has vital signs considered by the investigator to be clinically significant prior to study drug administration.
- Participant has had close contact with anyone confirmed to have SARS-CoV-2 infection within the 7 days prior to Day 1.
- Any acute drug therapy prescribed by a physician within 7 days prior to Day 1.
Where
- Las Vegas, Nevada
- Austin, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations