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

NCT06878170 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 4587C240015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• Occurrence, severity, and relationship of solicited local and general adverse events (AEs) during the 7 days following each vaccination.

  Day 1 to Day 8 after first vaccination, Day 22 to Day 29 after second vaccination

• Occurrence, severity, and relationship of unsolicited AEs during the 21 days following each vaccination

  Day 1 (post-vaccination) to Day 21 for first vaccination, Day 22 (post-vaccination) to Day 43

• Occurrence, severity and relationship of adverse events of special interest (AESIs) from the first vaccination through the 28 days following the second vaccination.

  Day 1 through Day 50

• Occurrence, severity, and relationship of medically-attended AEs (MAAEs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs) through the study completion

  Day 1 through Day 383 (End of study follow-up period)

• Occurrence of clinically significant changes in clinical laboratory results, vital signs results, 12-lead ECG results, and physical examination findings

  Day 1 through Day 383 (End of Study)

Secondary Outcomes (4)

• Geometric mean titer (GMT) of antigen specific antibody

  Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113

• The geometric mean fold rise (GMFR) in antigen specific antibody titer from baseline

  Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113

• Activation of SARS-CoV-2 specific cytotoxic T-cells and helper T-cells

  Day -1, Day 21, Day 43 and Day 113

• Assessment of specific cytokine levels from baseline through scheduled timepoints throughout study

  Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113

Study Arms (2)

RBM-001 Cohort 1

ACTIVE COMPARATOR

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

Biological: RBM-001

RBM-001 Cohort 2

ACTIVE COMPARATOR

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

Biological: RBM-001

Interventions

RBM-001 BIOLOGICAL

To evaluate the safety and tolerability of the RBM-001 vaccination in healthy adults.

RBM-001 Cohort 1; RBM-001 Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant female, aged 18 to 55 years old (inclusive) at the Screening visit.
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive) at the Screening visit.
• Physically and mentally capable of participating in the study and willing to adhere to study procedures.
• Able to provide signed informed consent.
• 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.
• Negative serology test for human immunodeficiency virus (HIV) antigen and antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.
• All female subjects must have a negative result of pregnancy test at the Screening visit.
• Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measures from the Screening Visit (unless otherwise stated) through end of study (EOS). Effective birth control includes:
• Progesterone implant (in place for at least 3 months prior to the Screening Visit) with condom
• Progesterone only hormonal contraception (oral or injectable; used consecutively for at least 3 months prior to the Screening Visit) with condom
• Progesterone releasing intrauterine device (IUD; in place for at least 3 months prior to the Screening Visit) with condom
• Non-hormonal IUD (in place for at least 3 months prior to the Screening Visit)
• Bilateral occlusion/tubal ligation
• Azoospermic partner
• Combined contraceptives (oral, intravaginal, transdermal, implantable, or injectable; in place for at least 3 months prior to the Screening Visit) plus condom; or

You may not qualify if:

• Any medical or psychiatric condition that, in the opinion of the Investigator, 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.
• Current, confirmed or suspected acute COVID-19 with positive test for SARS-CoV-2 virus at the Screening visit or at check-in for each period. Acute infection will be confirmed/excluded via symptoms and COVID-19 PCR or antigen testing, including positive COVID-19 PCR or rapid antigen test result within 3 months prior to Screening, reported verbally.
• Prior history of heart diseases of concern: history of myocarditis, pericarditis, cardiomyopathy, coronary artery disease (including history of myocardial infarction, unstable angina), Class III and above heart failure, or significant arrhythmias.
• Medical conditions as a contraindication to the IM vaccination and blood draws, e.g. coagulation disorder.
• Any abnormality or permanent body art (e.g. tattoo) that would interfere with the observation of local reactions at the injection site (deltoid region).
• Acute or chronic, clinically significant cardiovascular, pulmonary, hepatic or renal diseases and/or insufficiency as determined by physical examination or laboratory tests.
• Known or suspected impairment of immunological function, e.g. asplenia/splenectomy or history of autoimmune/immune-mediated diseases or lymphoproliferative disorders.
• History of any chronic or progressive disease that, according to judgment of the Investigator, could interfere with the study outcomes or pose a threat to the subject's health.
• History of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.
• History or presence of heavy smoking (defined as \> 10 cigarettes per day; approximately half pack per day) as documented in medical chart or by verbal confirmation at the Screening visit.
• Documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months prior to the Screening visit.
• Corrected QT using Fredericia's formula (QTcF) prolongation \> 450 milliseconds in males and \>470 milliseconds in females at Screening visit.
• Abnormal troponin (cardiac troponin; cTN) value at Screening visit.

Sponsors & Collaborators

• Rock BioMedical, Inc.: lead

Study Sites (1)

QPS Miami

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo control, double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 14, 2025
• Study Start: September 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: January 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-03

Locations

US (1)