COVID -19Phase 1NCT07445971
A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
A Phase 1 study testing MDX2301 and Normal Saline in people with COVID -19 and COVID-19 (Prevention), run by ModeX Therapeutics, An OPKO Health Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID -19, COVID-19 (Prevention)
- What is being tested?
- MDX2301 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Mar 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- Asthma
- Diabetes
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
TrialMed Clinical Research Unit
Austin, Texas, 78744
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Kristie Miller, MD
- Recruiting
TrialMed Clinical Research Unit
Las Vegas, Nevada, 89113
ModeX Therapeutics, +1 857-233-9936, info@modextx.com
Shawn Searle, MD
About this study
Official title: 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
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
- COVID -19, COVID-19 (Prevention)
- Being tested
- MDX2301, Normal Saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX2301Biological
MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
Normal SalineBiological
Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
Normal SalineBiological
Placebo as intramuscular injection or subcutaneous injection.
MDX2301Biological
MDX2301 as intramuscular injection or subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Healthy Adults MDX2301 | Experimental | Healthy Adults will receive a single dose of MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection. Receives: Biological: MDX2301 |
| Single Dose Healthy Adults Placebo | Placebo comparator | Healthy Adults will receive a single dose of placebo as intravenous infusion, intramuscular injection, or subcutaneous injection. Receives: Biological: Normal Saline |
| Repeat Dose Healthy Adults MDX2301 | Experimental | Healthy Adults will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection and then receive a repeat dose of MDX2301, 3 months later as intramuscular injection or subcutaneous injection. Receives: Biological: MDX2301 |
| Repeat Dose Healthy Adults Placebo | Placebo comparator | Healthy Adults will receive a single dose of placebo as intramuscular injection or subcutaneous injection and then receive a repeat dose of placebo 3 months later as intramuscular injection or subcutaneous injection. Receives: Biological: Normal Saline |
| Single-Dose Higher Risk Adults MDX2301 | Experimental | Adults at higher risk for severe COVID-19 will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection. Receives: Biological: MDX2301 |
| Single-Dose Higher Risk Adults Placebo | Placebo comparator | Adults at higher risk for severe COVID-19 will receive a single dose of placebo as intramuscular injection or subcutaneous injection. Receives: Biological: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.
Measured: Baseline until end of study, up to approximately 12 months
Secondary outcomes (7)
Measure of maximum serum concentration (Cmax) of MDX2301
Characterize pharmacokinetic (PK) parameter Cmax after administration of MDX2301
Measured: 12 months
Measure of time to maximum concentration (Tmax) of MDX2301
Characterize pharmacokinetic (PK) parameter Tmax after administration of MDX2301
Measured: 12 months
Measure of terminal half-life (t1/2) of MDX2301
Characterize pharmacokinetic (PK) parameter t1/2 after administration of MDX2301.
Measured: 12 months
Measure of area under the serum concentration-time curve (AUC) extrapolated to infinity of MDX2301
Characterize pharmacokinetic (PK) parameters AUC after administration of MDX2301
Measured: 12 months
Measure of volume of distribution (Vd) of MDX2301
Characterize pharmacokinetic (PK) parameter Vd after administration of MDX2301.
Measured: 12 months
Incidence of treatment-emergent anti-drug antibodies (ADA) of MDX-2301
Quantification of ADAs after MDX2301 administration
Measured: 12 months
Evaluation of serum virus neutralizing antibodies of MDX2301
Measure of the level of serum virus neutralizing antibodies of MDX2301 against relevant SARS-CoV-2 variants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID -19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModeX Therapeutics, An OPKO Health Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trial Med, Principal investigator, TrialMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445971
- Sponsor's protocol ID
- MDX-2301-101
- Other IDs
- 75A50123C00056
- Status last verified
- May 2026
- First submitted
- 10 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07445971
- Acronym / sponsor ID
- MDX-2301-101
- Conditions
- COVID -19, COVID-19 (Prevention)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ModeX Therapeutics, An OPKO Health CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single Dose Healthy Adults MDX2301 | Experimental | Biological: MDX2301Healthy Adults will receive a single dose of MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection. |
| Single Dose Healthy Adults Placebo | Placebo comparator | Biological: Normal SalineHealthy Adults will receive a single dose of placebo as intravenous infusion, intramuscular injection, or subcutaneous injection. |
| Repeat Dose Healthy Adults MDX2301 | Experimental | Biological: MDX2301Healthy Adults will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection and then receive a repeat dose of MDX2301, 3 months later as intramuscular injection or subcutaneous injection. |
| Repeat Dose Healthy Adults Placebo | Placebo comparator | Biological: Normal SalineHealthy Adults will receive a single dose of placebo as intramuscular injection or subcutaneous injection and then receive a repeat dose of placebo 3 months later as intramuscular injection or subcutaneous injection. |
| Single-Dose Higher Risk Adults MDX2301 | Experimental | Biological: MDX2301Adults at higher risk for severe COVID-19 will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection. |
| Single-Dose Higher Risk Adults Placebo | Placebo comparator | Biological: Normal SalineAdults at higher risk for severe COVID-19 will receive a single dose of placebo as intramuscular injection or subcutaneous injection. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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.
- 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:
Key exclusion criteria (27 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDX2301MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection. | Biological | Single Dose Healthy Adults MDX2301 |
| Normal SalinePlacebo as intravenous infusion, intramuscular injection, or subcutaneous injection. | Biological | Single Dose Healthy Adults Placebo |
| Normal SalinePlacebo as intramuscular injection or subcutaneous injection. | Biological | Repeat Dose Healthy Adults Placebo, Single-Dose Higher Risk Adults Placebo |
| MDX2301MDX2301 as intramuscular injection or subcutaneous injection. | Biological | Repeat Dose Healthy Adults MDX2301, Single-Dose Higher Risk Adults MDX2301 |
Primary outcome
Adverse Events
Time frame: Baseline until end of study, up to approximately 12 months
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.
7 secondary outcomes
Measure of maximum serum concentration (Cmax) of MDX2301
Time frame: 12 months
Measure of time to maximum concentration (Tmax) of MDX2301
Time frame: 12 months
Measure of terminal half-life (t1/2) of MDX2301
Time frame: 12 months
Measure of area under the serum concentration-time curve (AUC) extrapolated to infinity of MDX2301
Time frame: 12 months
Measure of volume of distribution (Vd) of MDX2301
Time frame: 12 months
Incidence of treatment-emergent anti-drug antibodies (ADA) of MDX-2301
Time frame: 12 months
Evaluation of serum virus neutralizing antibodies of MDX2301
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Med principal investigator
TrialMed
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDX2301 and Normal Saline in people with COVID -19 and COVID-19 (Prevention), run by ModeX Therapeutics, An OPKO Health Company at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ModeX Therapeutics, An OPKO Health Company (857-233-9936, info@modextx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Baseline until end of study, up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.