Actively Recruiting
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
Led by ModeX Therapeutics, An OPKO Health Company · Updated on 2026-03-04
80
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 64 years
- Healthy adults in good health as judged by the investigator
- Adults at higher risk for severe COVID-19 with one or more risk factors including asthma, diabetes, cerebrovascular disease, chronic kidney disease, chronic lung disease, cardiac disease, chronic liver disease, cystic fibrosis, stable HIV on antiretroviral therapy for at least 6 months, sickle cell disease, or thalassemia
- Clinically stable with no significant abnormalities
- No hospitalization within 12 months prior to screening and not expected to be hospitalized during the study
- Female participants of childbearing potential must have a negative pregnancy test
- Female participants must agree to use a highly effective birth control method
- Able to understand and sign the informed consent form
- Willing and able to comply with scheduled visits and procedures
You will not qualify if you...
- Any chronic or significant medical condition that may compromise safety or interfere with study evaluation
- Active HIV, hepatitis B, or hepatitis C infection at screening
- Serious disease or condition that may compromise safety or interfere with study results or lead to hospitalization or death during the study
- Abnormal vital signs, ECG, or lab values at screening or Day -1
- Positive test for SARS-CoV-2 infection at screening
- Self-reported COVID-19 or prior COVID-19 antiviral treatment before Day 1
- Prior receipt of SARS-CoV-2 vaccine before dosing
- Prior receipt of monoclonal antibody or convalescent plasma for SARS-CoV-2 before Day 1
- Receipt or expected receipt of immunoglobulin, blood products, high-dose corticosteroids, or immunosuppressants within 6 months prior to Day 1
- Pregnant, breastfeeding, or seeking pregnancy during study
- Known significant bleeding disorder prohibiting IV, IM, or SC administration
- Major surgery within 30 days prior to Day 1
- Blood donation prior to screening
- Skin conditions or tattoos interfering with injection site evaluation
- History of alcoholism, illicit drug use, or positive drug test at screening or Day -1
- Current daily smoker or nicotine product user
- Receipt of investigational product within 30 days prior to Day 1
- Known hypersensitivity to MDX2301 or its components
- Acute illness within 3 days of Day 1
- Clinically significant vital signs before drug administration
- Close contact with confirmed SARS-CoV-2 case within 7 days prior to Day 1
- Acute drug therapy prescribed within 7 days prior to Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
TrialMed Clinical Research Unit
Las Vegas, Nevada, United States, 89113
Actively Recruiting
2
TrialMed Clinical Research Unit
Austin, Texas, United States, 78744
Actively Recruiting
Research Team
M
ModeX Therapeutics, An OPKO Health Company
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
6
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