80 Participants NeededMy employer runs this trial

MDX2301 for COVID-19

Recruiting at 1 trial location
MT
Overseen ByModeX Therapeutics, An OPKO Health Company
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: ModeX Therapeutics, An OPKO Health Company
Must be taking: Antiretrovirals

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called MDX2301 for COVID-19. Researchers are evaluating how well the treatment works and how the body responds when administered through different methods, such as IV, muscle injections, or under the skin. The trial includes healthy adults and those at higher risk for severe COVID-19, such as individuals with asthma, diabetes, or heart disease. It suits adults who haven't had COVID-19 or been vaccinated and are willing to try a new treatment method. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant drugs, high-dose corticosteroids, or certain blood products, you may need to stop them 6 months before the study starts.

Is there any evidence suggesting that MDX2301 is likely to be safe for humans?

Research has shown that MDX2301 is being tested for safety in humans. This study explores various methods of administration, such as intravenous (IV), intramuscular injection, or subcutaneous injection.

Although detailed results are not yet available, MDX2301 is in a Phase 1 trial, where scientists assess its safety for humans. This phase typically marks the first step in human testing, focusing on ensuring the treatment is safe and generally well-tolerated.

Phase 1 trials usually involve small groups of healthy individuals and sometimes those at risk for the disease under study. The aim is to understand the body's reaction to the treatment and identify any side effects.

Overall, MDX2301 is in the early stages of testing, so safety information is still being collected. However, its testing indicates that earlier lab and animal studies showed sufficient promise to advance to human trials.12345

Why do researchers think this study treatment might be promising?

Unlike the standard COVID-19 treatments, which often involve antiviral drugs and vaccines, MDX2301 is unique because it targets the immune system differently. Researchers are excited about MDX2301 because it can be administered in various ways, including intravenous, intramuscular, or subcutaneous injections, offering flexibility in treatment delivery. Additionally, MDX2301 shows promise as a single or repeat dose treatment, potentially enhancing the immune response in both healthy and higher-risk adults. This versatility and innovative approach could lead to more effective prevention or mitigation of severe COVID-19 symptoms.

What evidence suggests that MDX2301 might be an effective treatment for COVID-19?

Research has shown that MDX2301 could be a promising treatment for COVID-19. This trial will evaluate MDX2301 in different groups, including healthy adults and higher-risk adults, with some receiving a single dose and others a repeat dose. Designed to work against all known versions of the virus that causes COVID-19, this antibody has shown in early lab studies that it can stop the virus from entering cells. This suggests MDX2301 might help prevent the disease from worsening. Although human studies have provided limited information so far, the mechanism of MDX2301 appears promising for effectively fighting COVID-19.16789

Who Is on the Research Team?

TM

Trial Med

Principal Investigator

TrialMed

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 64 who are either healthy or have conditions that increase their risk for severe COVID-19, such as asthma, diabetes, heart disease, chronic lung or kidney disease, or cerebrovascular disease. Participants must be considered in good health by the study doctor.

Inclusion Criteria

I have a condition that affects blood flow to my brain.
I have chronic kidney disease.
I have a heart condition.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single IV, IM, and SC doses of MDX2301 or placebo, followed by a repeat IM or SC dose approximately 3 months later

3 months

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and anti-drug antibodies

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • MDX2301

Trial Overview

The study is testing a new drug called MDX2301 given by IV, shot into muscle (IM), or under the skin (SC) compared to a placebo (salt water). Some participants will get repeat doses about three months apart. The main goal is to check safety and how the body reacts.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: Single-Dose Higher Risk Adults MDX2301Experimental Treatment1 Intervention
Group II: Single Dose Healthy Adults MDX2301Experimental Treatment1 Intervention
Group III: Repeat Dose Healthy Adults MDX2301Experimental Treatment1 Intervention
Group IV: Single Dose Healthy Adults PlaceboPlacebo Group1 Intervention
Group V: Repeat Dose Healthy Adults PlaceboPlacebo Group1 Intervention
Group VI: Single-Dose Higher Risk Adults PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ModeX Therapeutics, An OPKO Health Company

Lead Sponsor

Trials
2
Recruited
170+

Citations

A Study Evaluating MDX2301 in Healthy Adults and ...

This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 ...

OPKO Health's ModeX Therapeutics Initiates Clinical Trial ...

The study is evaluating the safety and tolerability of MDX2301 administered via different routes in healthy volunteers and in adults at high ...

OPKO Health's ModeX Therapeutics Initiates Clinical Trial ...

MDX2301 is a tetravalent bispecific antibody that has the potential to neutralize all known variants of SARS-CoV-2. The study is evaluating the ...

OPKO doses first subjects in Phase 1 COVID antibody trial

OPKO Health's ModeX Therapeutics Initiates Clinical Trial of MDX2301 for the Prevention of COVID-19 ... Primary endpoints are safety/tolerability; ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40691108/

Effectiveness of the monovalent XBB.1.5 COVID-19 vaccines

XBB.1.5 vaccines provided substantial protection against severe COVID-19 outcomes in the 2023-2024 season prior to the emergence of the JN.1 ...

MDX2301 for COVID-19 · Recruiting Participants for Phase ...

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 ...

MDX-2301 - Drug Targets, Indications, Patents

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

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40366666/

A four-week study on the toxicity of repeated intramuscular ...

The plant-derived SARS-CoV-2 vaccine appears safe following repeated administration over 4 wk and represents a promising alternative for potential use.

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37896939/

Long Term Follow-Up Study of a Randomized, Open-Label ...

This clinical trial aimed to investigate the safety and immunogenicity of high doses of AG0302-COVID19 when injected intramuscularly and intradermally.