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

60 Participants Needed

Trial Summary

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.

How does the drug RBM-001 for Coronavirus differ from other treatments?

RBM-001 is unique because it targets the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein, potentially neutralizing the virus by preventing it from binding to the ACE2 receptor on human cells. This mechanism is distinct from other treatments that may not specifically target this critical interaction site. ^{1 2 3 4 5}

What is the purpose of this trial?

A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A SARS-CoV-2 Spike Receptor Binding Motif Peptide Induces Anti-Spike Antibodies in Mice andIs Recognized by COVID-19 Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Structural Basis of a Human Neutralizing Antibody Specific to the SARS-CoV-2 Spike Protein Receptor-Binding Domain. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Reconstitution of the receptor-binding motif of the SARS coronavirus. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Neutralization or enhancement of SARS-CoV-2 infection by a monoclonal antibody targeting a specific epitope in the spike receptor-binding domain. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Key residues of the receptor binding motif in the spike protein of SARS-CoV-2 that interact with ACE2 and neutralizing antibodies. [2022]