RBM-001 for Coronavirus

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Rock BioMedical, Inc.

No Placebo Group

Trial Summary

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

+6 more

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

+22 more

Participant Groups

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.

2Treatment groups

Active Control

Group I: RBM-001 Cohort 2Active Control1 Intervention

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

Group II: RBM-001 Cohort 1Active Control1 Intervention

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