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New treatment option for COVID -19
Official title A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
ClinicalTrials.gov ID: NCT07445971
What this study is testing
What is MDX2301?
MDX2301 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for covid -19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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:
You likely can't join if
- Healthy Adults
- Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or...
- 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...
- 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.
See the full eligibility 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:
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Las Vegas, Nevada, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Las Vegas, Nevada, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.