A Phase 1 interventional study of BMI2012 low-dose and Placebo low-dose in Prevention of COVID-19 Variant (Omicron JN.1), sponsored by BMI Korea. Not yet recruiting at 3 sites in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by BMI Korea · Phase 1, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 90 studies in COVID-19 with a site in Korea, Republic of — 11 open to participants now, 19 under way, 6 of them phase 3. COVID-19 · Korea, Republic of.
Among the 90 studies in COVID-19 with a site in Korea, Republic of, this one is the 45th largest by planned enrollment of the 72 interventional ones that give a count, is one of 4 that started in 2026, is one of 14 in phase 1, reaches primary completion later than 14 of the 18 other live ones, and was the 89th registered.
7,993 studies on the registry are indexed under COVID-19; 467 are open to participants now.
Browse COVID-19 studies →11 of the 90 studies in COVID-19 with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Pfizer · Sites in Korea, Republic of, United States, Argentina and 15 more countries
Ages 18+
Pfizer · Sites in Korea, Republic of, United States, Argentina and 16 more countries
Ages 12+
Merck Sharp & Dohme LLC · Sites in Korea, Republic of, United States, Argentina and 21 more countries
Ages 18+
Jaehoon Ko · Sites in Korea, Republic of
Ages 19+
Pfizer · Sites in Korea, Republic of
Ages 19+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.
This study: 19 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
90 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 20 · Phase 2 31 · Phase 3 30 · Phase 4 2
First in 2018; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is below the median of 102 across 4,366 interventional studies indexed under COVID-19.
Median enrollment 253 across the 72 interventional studies, 730 across the 18 observational. Of the 58 that completed or were terminated, 21 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
64 of 90 have an industry lead sponsor. The 10 most frequent:
BMI Korea is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
BMI Korea has 1 study filed under COVID-19 — fewer than ten, so there is no comparison to draw.
7 of the studies in COVID-19 with a site in Korea, Republic of that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT06613984PfizerKorean Post Marketing Surveillance for Comirnaty Injection (Bretovameran) | 2026-12-30 |
| NCT05032976PfizerKorea Comirnaty Post-marketing Surveillance | 2027-01-24 |
Add all 7 to your calendar (.ics) → With an account.
Among the 90 studies in COVID-19 with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This Phase 1, multi-center, randomized, double-blind, placebo-controlled, dose-escalation study evaluates the safety, tolerability, and immunogenicity of BMI2012, a self-amplifying RNA vaccine candidate targeting the SARS-CoV-2 Omicron JN .1 variant, in healthy adults aged 19 to 55 years.
Participants will be enrolled sequentially into three ascending-dose cohorts and randomized within each cohort to receive a single intramuscular injection of BMI2012 or placebo. A sentinel dosing strategy with staggered administration will be used to monitor safety before enrollment of the remaining participants in each dose cohort. A Data Safety Monitoring Board (DSMB) will review safety data to determine whether enrollment may continue and to assess dose levels appropriate for further clinical development.
The primary objective is to assess the safety and tolerability of BMI2012 across the dose levels studied. Secondary objectives include exploratory evaluation of humoral and cell-mediated immune responses to BMI2012 through 52 weeks after vaccination.
[Inclusion Criteria]
Male and female subjects of who have been using a highly effective method of from at least 14 days prior to the screening visit and agree to continue using a highly effective method of contraception** up to 12 weeks after IP administration *Male subjects: Sexual abstinence, or the use of a condom, with the partner of reproductive potential using a highly effective method of contraception** *Female subjects: Use of a highly effective method of contraception**
[Exclusion Criteria]
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: BMI2012 low-dose
Other: Placebo low-dose
Biological: BMI2012 mid-dose
Other: Placebo mid-dose
Biological: BMI2012 high-dose
Other: Placebo high-dose
Self-amplifying RNA vaccine encoding the SARS-CoV-2 (Omicron JN.1) spike protein. Administered as a single low-dose intramuscular injection at Visit 2
Normal saline solution administered as a single intramuscular injection at visit 2, volume-matched to BMI2012 low-dose
Self-amplifying RNA vaccine encoding the SARS-CoV-2 (Omicron JN.1) spike protein. Administered as a single mid-dose intramuscular injection at Visit 2
Normal saline solution administered as a single intramuscular injection at visit 2, volume-matched to BMI2012 mid-dose
Self-amplifying RNA vaccine encoding the SARS-CoV-2 (Omicron JN.1) spike protein. Administered as a single high-dose intramuscular injection at Visit 2
Normal saline solution administered as a single intramuscular injection at visit 2, volume-matched to BMI2012 high-dose
Incidence of Adverse Events Following Investigational Product Administration
Time frame: From administration through Day 28
Incidence of Long-Term SAEs, MAAEs, and AESIs
Time frame: From administration through Week 52
Clinical Safety Assessments
Clinical laboratory test results, vital signs, physical examination findings, and ECG findings will be assessed after administration of BMI2012 or placebo
Time frame: From baseline through the last scheduled clinical safety assessment
Humoral and Cell-Mediated Immune Response to BMI2012
Time frame: Day 28, Week 26, and Week 52 after administration
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 233 industry-sponsored phase 1 interventional studies under COVID-19, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's planned 14 months is above that.
Counting every sponsor, half of 384 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BMI Korea