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cH15/3 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1, Arm1 | EXPERIMENTAL | Healthy adults will receive 2 monovalent dose intramuscular injections. cH8/1 (25ug) chimeric Hemagglutinin (HA) is the first dose given on Day 1, followed by a second dose administered 57 days later with cH5 /1(25 ug). N = 10 |
| Cohort 1, Arm2 | EXPERIMENTAL | Healthy adults will receive 2 monovalent dose intramuscular injections. cH15/3 (25ug) chimeric HA is the first dose given on Day 1, followed by a second dose of cH4/3 (25ug), administered 57 days later. N = 10. |
| Cohort 1, Arm3 | EXPERIMENTAL | Healthy adults will receive 2 low dose bivalent intramuscular injections. cH8/1(12.5ug) + cH15/3 (12.5ug) chimeric HA is the first dose given on Day 1, followed by a second dose of cH5/1 (12.5ug) + cH4/3(12.5 ug) administered 57 days later. N = 10. |
| Cohort 2, Arm4 | EXPERIMENTAL | Healthy adults will receive a single high dose bivalent combination intramuscular injection along with a placebo dose. cH8/1(25ug) + cH15/3(25ug) will be administered on Day 1, followed by a placebo dose 57 days later. N = 10. |
| Cohort 2, Arm5 | EXPERIMENTAL | Healthy adults will receive a single high dose bivalent combination intramuscular injection along with a placebo dose. cH5/1(25ug) + cH4/3(25ug) will be administered on Day 1, followed by a placebo dose 57 days later. N = 10. |
| Cohort 2, Arm6 | EXPERIMENTAL | Healthy adults will receive 2 high dose bivalent intramuscular injections. cH8/1(25ug) + cH15/3 (25ug) is the first dose given on Day 1, followed by the second dose of cH5/1(25 ug) + cH4/3 (25 ug) administered 57 days later. N = 10. |
| Name | Type | Description |
|---|---|---|
| cH15/3 | BIOLOGICAL | The cH15/3 RNA study product encodes for a novel chimeric hemagglutinin comprised of an H15 HA head domain derived from influenza A/wedge-tailed shearwater/Western Australia/2576/1979 (H15N9) and the conserved stem domain derived from influenza A/Hong Kong/2014 (H3N2) (GenBank: OQ349633). The cH15/3 RNA is encapsulated in LNPs for delivery. The LNP is comprised of 4 lipid components: ionizable lipid (ALC-0315), distearoylphosphatidylcholine (DSPC), cholesterol (non-animal derived), and PEG lipid (ALC-0159). |
| cH4/3 | BIOLOGICAL | The cH4/3 RNA encodes a novel chimeric hemagglutinin comprised of an H4 head domain from A/duck/Czechoslovakia/1956 (H4N6) and a conserved stem domain from A/Hong Kong/2014 (H3N2) (GenBank: OQ349617), delivered via lipid nanoparticles (LNPs) containing ionizable lipid (ALC-0315), distearoylphosphatidylcholine (DSPC), cholesterol (non-animal derived), and PEG lipid (ALC-0159). |
| cH5/1N1 | BIOLOGICAL | cH5/1N1 is a H1N1 influenza vaccine: egg grown split inactivated influenza virus vaccines containing chimeric hemagglutinins (HAs). The chimeric viruses contain the globular heads of exotic viruses- and the HA stem domain and neuraminidase protein from currently circulating seasonal H1N1. |
| cH8/1N1 | BIOLOGICAL | cH8/1N1 is a H1N1 influenza vaccine: egg grown split inactivated influenza virus vaccines containing chimeric hemagglutinins (HAs). The chimeric viruses contain the globular heads of exotic viruses- and the HA stem domain and neuraminidase protein from currently circulating seasonal H1N1. |
| Saline | DRUG | Sodium chloride solution. |
Inclusion Criteria: 1. Provision of signed and dated informed consent form before the initiation of any study procedures. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Non-pregnant healthy adults, aged 18 to 59 years of age, inclusive, ...
cH15/3 is an investigational monoclonal antibody being developed for influenza. It is currently in Phase 1 clinical development, with a trial studying its safety and immunogenicity as part of a chimeric hemagglutinin mRNA vaccine candidate. The drug is not yet approved and remains under investigation.
cH15/3 is being developed by National Healthcare Corp. (NHC). The company is conducting a Phase 1 clinical trial for this investigational monoclonal antibody, which is being studied for its potential use in influenza.
cH15/3 is in Phase 1 clinical development. It is an investigational monoclonal antibody being studied for influenza, and it is not yet approved by regulatory authorities. The Phase 1 trial is designed to evaluate safety and immunogenicity.
cH15/3 is being studied in a Phase 1 clinical trial with the identifier NCT07703514, titled 'Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates.' The trial is not yet recruiting and aims to enroll 60 participants in the United States.
cH15/3 is a monoclonal antibody, but it is being studied in a trial that evaluates chimeric hemagglutinin mRNA vaccine candidates. The trial, NCT07703514, is investigating the safety and immunogenicity of these vaccine candidates, which may include cH15/3 as a component.