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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.

A Phase 1a/b Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19

A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19. (NCT07445971) is a Phase 1 interventional studying COVID -19 and COVID-19 (Prevention), sponsored by ModeX Therapeutics, An Opko Health Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For COVID -19, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused COVID -19 subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria Healthy Adults 1. Participant is a healthy male or female, 18 to 64 years of age. 2. Participant is in good health in the opinion of the investigator. Adults at Higher Risk for Developing Severe COVID-19: 3. Participant is a male or female, 18 to 64 years of age. 4. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors: 1. Asthma 2. Diabetes 3. Cerebrovascular disease, which affects blood flow to the brain. 4. Chronic kidney disease 5. Chronic lung disease 6. Cardiac disease 7. Chronic liver disease 8. Cystic fibrosis 9. HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening. 10. Sickle cell disease or thalassemia 5. Participant is clinically stable with no clinically significant abnormalities. 6. 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 7. Female participants of childbearing potential must have a negative urine pregnancy test. 8. Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method. 9. Participant is able to understand and sign the willing to sign a consent form form prior to undergoing any study procedures. 10. Participant is willing and able to comply with scheduled visits and procedures. Who Should NOT Join This Trial: Healthy Adults 1. 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. 2. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening. Adults at Higher Risk for Severe COVID-19: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria Healthy Adults 1. Participant is a healthy male or female, 18 to 64 years of age. 2. Participant is in good health in the opinion of the investigator. Adults at Higher Risk for Developing Severe COVID-19: 3. Participant is a male or female, 18 to 64 years of age. 4. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors: 1. Asthma 2. Diabetes 3. Cerebrovascular disease, which affects blood flow to the brain. 4. Chronic kidney disease 5. Chronic lung disease 6. Cardiac disease 7. Chronic liver disease 8. Cystic fibrosis 9. HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening. 10. Sickle cell disease or thalassemia 5. Participant is clinically stable with no clinically significant abnormalities. 6. 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 7. Female participants of childbearing potential must have a negative urine pregnancy test. 8. Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method. 9. Participant is able to understand and sign the informed consent form prior to undergoing any study procedures. 10. Participant is willing and able to comply with scheduled visits and procedures. Exclusion Criteria: Healthy Adults 1. 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. 2. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening. Adults at Higher Risk for Severe COVID-19: 3. 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. 4. Participant has evidence of active hepatitis B or hepatitis C infections at screening. All Participants 5. Participant has abnormal vital signs, ECG findings, or laboratory values at Screening or Day -1. 6. Participant tests positive for SARS-CoV-2 infection at screening. 7. Participant self-reports having COVID-19 or received COVID-19 antiviral for prophylaxis or treatment prior to Day 1. 8. Participant has received a SARS-CoV-2 vaccine prior to dosing. 9. Participant has received a monoclonal antibody (mAb) for SARS-CoV-2 or convalescent plasma for SARS-CoV-2 prior to Day 1. 10. 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. 11. Participant is pregnant, breastfeeding, or seeking pregnancy while on the study. 12. Participant with a known clinically significant bleeding disorder that would prohibit the participant from receiving an IV infusion or IM or SC injection. 13. Participant had major surgery within 30 days prior to Day 1. 14. Participant has donated blood prior to screening. 15. Participant has any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site. 16. 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. 17. Participant is a current smoker or user of other nicotine containing products on a daily basis. 18. Participant has received an investigational product within 30 days prior to Day 1. 19. 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: 20. Participant has any acute illness, within 3 days of Day 1. 21. Participant has vital signs considered by the investigator to be clinically significant prior to study drug administration. 22. Participant has had close contact with anyone confirmed to have SARS-CoV-2 infection within the 7 days prior to Day 1. 23. Any acute drug therapy prescribed by a physician within 7 days prior to Day 1.

Treatments Being Tested

BIOLOGICAL

MDX2301

MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.

BIOLOGICAL

Normal Saline

Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.

BIOLOGICAL

Normal Saline

Placebo as intramuscular injection or subcutaneous injection.

BIOLOGICAL

MDX2301

MDX2301 as intramuscular injection or subcutaneous injection.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

TrialMed Clinical Research Unit
Las Vegas, Nevada, United States
TrialMed Clinical Research Unit
Austin, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07445971), the sponsor (ModeX Therapeutics, An Opko Health Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07445971 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07445971?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07445971?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07445971. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07445971. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.