COVID-19Phase 1NCT06878170
A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
A Phase 1 study testing RBM-001 in people with COVID-19, run by Rock BioMedical, Inc. at 1 site in United States.
Trial summary
A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- RBM-001
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 26 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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
- Sexual abstinence as the preferred lifestyle (refraining from heterosexual activity) Women of childbearing potential are those who have not been surgically sterilized (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or are not postmenopausal, defined as no menses for ≥ 12 months without alternative cause with confirmatory laboratory levels.
- Male subject who agrees to use an adequate method of contraception during the study period (e.g. barrier contraceptives [male condom]).
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Received any investigational or licensed COVID-19 vaccines within 6 months prior to the Screening visit.
- Received marketed inactivated vaccines against seasonal influenza within 7 days prior to the study vaccination, any other inactivated vaccination within 14 days prior to the study vaccination, or live or bacterial vaccination within 28 days prior to the study vaccination or plans to receive vaccination during the study period or within the 14 days following study vaccination.
- Received major surgery or radiation therapy within 3 months prior to the Screening visit.
- Onset of influenza-like illness as defined by: fever (temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production, dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat within 1 week prior to the Screening visit and within 48-hours of each vaccination. Subject can be re-evaluated after resolution of symptoms within the screening window.
- Female subject who is pregnant at the Screening visit or planning to be pregnant during the study period.
- Female subject who is breastfeeding at the Screening visit or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
- Received any investigational mRNA COVID-19 vaccination within 6 months prior to the Screening visit or have received any other investigational drug or device or have participated in a clinical study within 28 days or 5 half-lives of investigational drug prior to the Screening visit.
- Any confirmed or suspected abnormal immune function, immunosuppression, or immunodeficiency or received any immunosuppressants (including systemic corticosteroids) or immunomodulators within 3 months prior to the Screening visit.
- Had donated blood within 2 weeks prior to the Screening visit.
- Received any blood products or immunoglobulin within 3 months prior to the Screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
Read the detailed description
This was a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, and immunogenicity of RBM-001 in healthy adults. Participants were randomized to receive RBM-001 at 5 µg or 25 µg, or placebo, administered by intramuscular injection. Two vaccinations were planned 21 days apart. Safety and tolerability were assessed through solicited and unsolicited adverse events, adverse events of special interest, medically attended adverse events, new-onset chronic medical conditions, serious adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and physical examinations. Immunogenicity assessments included antigen-specific antibody responses, SARS-CoV-2-specific T-cell responses, and cytokine responses.
- Conditions
- COVID-19
- Being tested
- RBM-001
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBM-001Biological
To evaluate the safety and tolerability of the RBM-001 vaccination in healthy adults.
| Study group | Role | What they receive |
|---|---|---|
| RBM-001 Cohort 1 | Active comparator | Low-dose study vaccine administered via intra-muscular injection. Receives: Biological: RBM-001 |
| RBM-001 Cohort 2 | Active comparator | High-dose study vaccine administered via intra-muscular injection. Receives: Biological: RBM-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, severity, and relationship of solicited local and general adverse events (AEs) during the 7 days following each vaccination.
Number and percentage of participants with solicited local and general adverse events, summarized by severity and relationship to study vaccination.
Measured: 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
Number and percentage of participants with unsolicited adverse events, summarized by severity and relationship to study vaccination.
Measured: 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.
Number and percentage of participants with adverse events of special interest (AESIs), summarized by severity and relationship to study vaccination.
Measured: 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
Number and percentage of participants with medically attended adverse events (MAAEs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs), summarized by severity and relationship to study vaccination, as applicable.
Measured: 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
Number and percentage of participants with clinically significant changes in clinical laboratory results, vital signs, 12-lead electrocardiogram results, and physical examination findings.
Measured: Day 1 through Day 383 (End of Study)
Secondary outcomes (4)
Geometric mean titer (GMT) of antigen specific antibody
Antigen-specific antibody titers measured by enzyme-linked immunosorbent assay (ELISA) and summarized as geometric mean titers (GMTs) at scheduled study time points.
Measured: 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
Antigen-specific antibody titers measured by ELISA and summarized as geometric mean fold rise (GMFR) from baseline at scheduled post-vaccination time points.
Measured: 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
SARS-CoV-2 antigen-specific cytotoxic CD8+ T-cell and helper CD4+ T-cell responses assessed by flow cytometry at scheduled study time points.
Measured: Day -1, Day 21, Day 43 and Day 113
Assessment of specific cytokine levels from baseline through scheduled timepoints throughout study
Cytokine responses assessed at scheduled study time points, including IL-2, IL-12, TNF-α, IFN-γ, IL-1β, IL-4, IL-6, IL-8, IL-10, and IL-13.
Measured: Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start30 Sep 2024
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rock BioMedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878170
- Sponsor's protocol ID
- 4587C240015
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06878170
- Acronym / sponsor ID
- 4587C240015
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rock BioMedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A First in Human Study to Evaluate the Safety and Immunogenicity of RBM-001 in Healthy Adult Volunteers
Detailed description
This was a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, and immunogenicity of RBM-001 in healthy adults. Participants were randomized to receive RBM-001 at 5 µg or 25 µg, or placebo, administered by intramuscular injection. Two vaccinations were planned 21 days apart. Safety and tolerability were assessed through solicited and unsolicited adverse events, adverse events of special interest, medically attended adverse events, new-onset chronic medical conditions, serious adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and physical examinations. Immunogenicity assessments included antigen-specific antibody responses, SARS-CoV-2-specific T-cell responses, and cytokine responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBM-001 Cohort 1 | Active comparator | Biological: RBM-001Low-dose study vaccine administered via intra-muscular injection. |
| RBM-001 Cohort 2 | Active comparator | Biological: RBM-001High-dose study vaccine administered via intra-muscular injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBM-001To evaluate the safety and tolerability of the RBM-001 vaccination in healthy adults. | Biological | RBM-001 Cohort 1, RBM-001 Cohort 2 |
Primary outcome
Occurrence, severity, and relationship of solicited local and general adverse events (AEs) during the 7 days following each vaccination.
Time frame: Day 1 to Day 8 after first vaccination, Day 22 to Day 29 after second vaccination
Number and percentage of participants with solicited local and general adverse events, summarized by severity and relationship to study vaccination.
Occurrence, severity, and relationship of unsolicited AEs during the 21 days following each vaccination
Time frame: Day 1 (post-vaccination) to Day 21 for first vaccination, Day 22 (post-vaccination) to Day 43
Number and percentage of participants with unsolicited adverse events, summarized by severity and relationship to study vaccination.
Occurrence, severity and relationship of adverse events of special interest (AESIs) from the first vaccination through the 28 days following the second vaccination.
Time frame: Day 1 through Day 50
Number and percentage of participants with adverse events of special interest (AESIs), summarized by severity and relationship to study vaccination.
Occurrence, severity, and relationship of medically-attended AEs (MAAEs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs) through the study completion
Time frame: Day 1 through Day 383 (End of study follow-up period)
Number and percentage of participants with medically attended adverse events (MAAEs), new-onset chronic medical conditions (NOCMCs), and serious adverse events (SAEs), summarized by severity and relationship to study vaccination, as applicable.
Occurrence of clinically significant changes in clinical laboratory results, vital signs results, 12-lead ECG results, and physical examination findings
Time frame: Day 1 through Day 383 (End of Study)
Number and percentage of participants with clinically significant changes in clinical laboratory results, vital signs, 12-lead electrocardiogram results, and physical examination findings.
4 secondary outcomes
Geometric mean titer (GMT) of antigen specific antibody
Time frame: 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
Time frame: 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
Time frame: Day -1, Day 21, Day 43 and Day 113
Assessment of specific cytokine levels from baseline through scheduled timepoints throughout study
Time frame: Day -1, Day 8, Day 15, Day 21, Day 29, Day 36, Day 43 and Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for COVID-19
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RBM-001 in people with COVID-19, run by Rock BioMedical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence, severity, and relationship of solicited local and general adverse events (AEs) during the 7 days following each vaccination. (time frame: Day 1 to Day 8 after first vaccination, Day 22 to Day 29 after second vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.