Actively Recruiting
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
Led by ModeX Therapeutics, An OPKO Health Company · Updated on 2026-05-18
80
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MDX2301, a biological drug administered by intravenous, intramuscular, or subcutaneous routes, in healthy adults and adults at higher risk for severe COVID-19. This phase 1a/b randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, anti-drug antibody response, and virus neutralizing activity of MDX2301. The study includes adults aged 18 to 64 years and explores different administration routes and dosing schedules to better understand how the drug behaves in the body and its immune effects. Participants will be assigned to receive either MDX2301 or placebo through various routes: healthy adults may receive a single dose via intravenous infusion, intramuscular injection, or subcutaneous injection, or a repeat intramuscular or subcutaneous dose about three months apart. Adults at higher risk for severe COVID-19 will receive a single intramuscular or subcutaneous dose of MDX2301 or placebo. The study uses a randomized, quadruple-masked design to compare these groups and monitor responses over time. Throughout the study, participants will be monitored for adverse events from baseline up to approximately 12 months. Blood samples will be collected to measure drug concentration over time, half-life, volume of distribution, and presence of anti-drug antibodies. Researchers will also evaluate the virus neutralizing antibodies in participants' serum. Regular visits and assessments will ensure participant safety and collect data on how MDX2301 is processed by the body and its immune effects during the study period.
CONDITIONS
Brief 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...
- Healthy male or female adults aged 18 to 64 years.
- Good health as determined by the investigator.
- Adults at higher risk for severe COVID-19 aged 18 to 64 years with one or more risk factors such as asthma, diabetes, cerebrovascular disease, chronic kidney disease, chronic lung disease, cardiac disease, chronic liver disease, cystic fibrosis, stable HIV on therapy, 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 and agree to effective birth control.
- Ability to understand and sign informed consent.
- Willingness and ability to comply with scheduled visits and procedures.
You will not qualify if you...
- Any chronic or significant medical condition that may affect safety or study evaluation.
- Active HIV, hepatitis B, or hepatitis C infection at screening (for healthy adults).
- Serious diseases or conditions that may cause hospitalization or death during the study (for higher risk adults).
- Abnormal vital signs, ECG, or lab values at screening or Day -1.
- Positive test for SARS-CoV-2 infection at screening.
- Prior COVID-19 antiviral treatment or infection before Day 1.
- Prior SARS-CoV-2 vaccination before dosing.
- Prior monoclonal antibody or convalescent plasma for SARS-CoV-2 before Day 1.
- Use of immunoglobulin, blood products, high-dose steroids, or immunosuppressants within 6 months before Day 1.
- Pregnancy, breastfeeding, or seeking pregnancy.
- Clinically significant bleeding disorder preventing IV or injection administration.
- Major surgery within 30 days before Day 1.
- Recent blood donation before screening.
- Skin conditions or tattoos interfering with injection site safety evaluation.
- History or current use of illicit drugs, alcoholism, or daily nicotine use.
- Recent investigational product use within 30 days before Day 1.
- Known hypersensitivity to MDX2301 or its components.
- Acute illness within 3 days before Day 1.
- Clinically significant vital signs before drug administration.
- Close contact with confirmed COVID-19 case within 7 days before Day 1.
- Recent acute drug therapy within 7 days before Day 1.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive one or two doses of MDX2301 or placebo via intravenous infusion, intramuscular injection, or subcutaneous injection depending on their assigned group.
1 to 2 visits depending on dosing schedule
Duration - Up to approximately 12 months
Participants are monitored for safety and biological measures for up to 12 months after dosing.
Periodic visits for safety and blood sample collection
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
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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