RBM-001 for Coronavirus

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Rock BioMedical, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Heart disease, Cancer, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, RBM-001, to assess its safety and the immune system's response. It targets healthy adults who have not recently had COVID-19 and are generally in good health. Participants will receive either a low or high dose of the vaccine to compare effects. Suitable candidates are healthy, have not smoked heavily, and do not have serious medical conditions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressants or immunomodulators, you may need to stop, as these are excluded if taken within 3 months prior to the screening visit.

Is there any evidence suggesting that RBM-001 is likely to be safe for humans?

Research shows that RBM-001 is being studied for its ability to create strong antibodies against COVID-19. In similar studies with related treatments, researchers have focused on safety and tolerability. For example, some early studies found that a similar method using virus-like particles was well-tolerated by participants, with no serious side effects reported.

However, since RBM-001 is in the early stages of testing, the main goal is to assess its safety for humans. Detailed information about its safety is still being collected. In this early phase, researchers are still learning about its tolerability.

In summary, while there is some encouraging data from related treatments, the specific safety of RBM-001 in humans is still under investigation. Participants in this trial will help determine the safety and effectiveness of RBM-001. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RBM-001 is unique because it explores different dosage levels of a new vaccine designed to combat coronavirus, administered via intramuscular injection. Unlike many current treatments that focus on antiviral medications or monoclonal antibodies, RBM-001 is a vaccine that aims to stimulate the body’s immune response to prevent or mitigate infection. Researchers are excited about RBM-001's potential to offer both low-dose and high-dose options, which might provide flexibility in treatment and potentially enhance the immune response with fewer side effects. This approach could lead to more effective prevention strategies and broaden the arsenal against the virus.

What evidence suggests that RBM-001 might be an effective treatment for coronavirus?

Research has shown that RBM-001 targets a specific part of the virus called the receptor-binding motif (RBM). This part helps create strong neutralizing antibodies, which are proteins that can prevent the virus from infecting cells. One study found that using the RBM in a vaccine triggered a strong immune response against COVID-19. Another study using a similar method in a vaccine also showed promising results. These early findings suggest that RBM-001, administered to participants in this trial in either a low-dose or high-dose form, might help the body fight the virus effectively. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to participate in a first-time study of a new vaccine, RBM-001, aimed at preventing coronavirus. Specific eligibility criteria are not provided here.

Inclusion Criteria

In generally good health with no clinically significant abnormal findings in medical history, physical examination, vital signs, ECG, and clinical laboratory findings at the Screening visit based on the Investigator's judgment

Body mass index (BMI) of 18.0 to 32.0 kg/m2 at the Screening visit

Able to provide signed informed consent

Exclusion Criteria

Any medical or psychiatric condition that may interfere with optimal participation in the study or place the subject at increased risk of Adverse Events (AEs)

Suspected or known hypersensitivity (including allergy) to any of the ingredients or components in the study vaccine

History of hypersensitivity or allergy to any vaccine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a high-dose or low-dose of the RBM-001 vaccine via intra-muscular injection

6 weeks

Follow-up

Participants are monitored for safety and immunogenicity after receiving the vaccine

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RBM-001

Trial Overview The trial is testing the safety and how well the immune system responds to RBM-001, which is a new vaccine candidate for coronavirus. This initial study involves people receiving the vaccine to assess its effects.

How Is the Trial Designed?

Group I: RBM-001 Cohort 2 Active Control 1 Intervention

High-dose study vaccine administered via intra-muscular injection.

Group II: RBM-001 Cohort 1 Active Control 1 Intervention

Low-dose study vaccine administered via intra-muscular injection.

Who Is Running the Clinical Trial?

Rock BioMedical, Inc.

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12008496/

Recombinant receptor-binding motif of spike COVID-19 ... This study investigates the use of the receptor-binding motif (RBM) domain as an immunogen to produce potent neutralizing antibodies against SARS-CoV-2.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8619050/

A Novel Double Mosaic Virus-like Particle-Based Vaccine ... A novel double mosaic virus-like particle-based vaccine against SARS-CoV-2 incorporates both receptor binding motif (RBM) and fusion domain.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590136225000580

Neutralizing antibody responses to SARS-CoV-2 variants ... Our analysis revealed that the neutralization efficacy of sera from individuals with the initial two-dose vaccination series was significantly diminished ...

4. nature.com nature.com/articles/s42003-023-04782-6

Structural basis of spike RBM-specific human antibodies ... The decrease of antibody efficacy to mutated SARS-CoV-2 spike RBD explains the breakthrough infections and reinfections by Omicron variants.

5. biorxiv.org biorxiv.org/content/10.1101/2025.05.12.653592v2.full-text

Generative model of SARS-CoV-2 variants under immune ... After training an RBM on an MSA containing data from coronaviruses predating SARS-CoV-2 (see SI Figures S1a-b), we first assessed whether the RBM log ...

6. nature.com nature.com/articles/s41591-025-03969-0

Safety and pharmacokinetics of SARS-CoV-2 DNA- ... To translate these findings to humans, we conducted a phase 1, dose-escalation trial assessing the safety, tolerability and pharmacokinetics of ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2027906

Safety and Immunogenicity of Two RNA-Based Covid-19 ... Here, we report the full set of safety and immunogenicity data from the phase 1 portion of an ongoing randomized, placebo-controlled, observer- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04368728

NCT04368728 | Study to Describe the Safety, Tolerability, ... The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 ...