Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JCXH-221 · 1 trial · 2 indications
Frequency of serious adverse events (SAEs) characterized by type, severity, duration, and drug relationship, from Day 1 (dosing day) until follow-up completion
Solicited local reactions at the injection site characterized by frequency, severity, and duration, recorded up to 7 days after dosing (Day 8)
Solicited systemic reactions characterized by frequency, severity, duration, and drug relationship, recorded up to 7 days after dosing (Day 8)
Adverse events (AEs), including unsolicited AEs, characterized by frequency, severity, duration, and drug relationship, for up to 28 days after dosing (Day 29)
The proportion of subjects with at least 1 unsolicited treatment-emergent AE occurring up to 28 days after dosing (Day 29)
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and drug relationship, from Day 1 until follow-up completion
| Arm | Type | Description |
|---|---|---|
| Investigational product | EXPERIMENTAL | Patients randomized to this arm will be given the investigational product (JCXH-221). |
| Placebo | PLACEBO_COMPARATOR | Patients randomized to this arm will be given a placebo vaccine. |
| Name | Type | Description |
|---|---|---|
| JCXH-221 | BIOLOGICAL | Participants will be randomized to either placebo or JCXH-221 for Phase 1. For Phase 2, participants will either be randomized to JCXH-221 or a FDA approved Active comparator. |
| Placebo | OTHER | Participants will be randomized in Phase 1 to either JCXH-221 or placebo |
Main Inclusion Criteria * Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. * Age: 18 years of age or older, at screening. * Status: Healthy subjects. * Subjects must have completed the full doses for primary vaccination with an ...
JCXH-221 is an investigational monoclonal antibody being developed for the prevention or treatment of COVID-19. It is currently in Phase 1 clinical development as a broadly protective vaccine against COVID-19, according to a completed clinical trial. The drug is being studied in healthy volunteers aged 18 years and older.
JCXH-221 is being developed by Icon Plc, a company traded on the NASDAQ under the ticker ICLR. The drug is an investigational monoclonal antibody for COVID-19 and is currently in Phase 1 clinical development.
JCXH-221 is in Phase 1 clinical development. A Phase 1 study assessing the safety and immunogenicity of JCXH-221 as an mRNA-based broadly protective COVID-19 vaccine has been completed. The drug is investigational and has not been approved by regulatory authorities.
JCXH-221 has one completed clinical trial, identified as NCT05743335. This Phase 1 study assessed the safety and immunogenicity of JCXH-221 as an mRNA-based broadly protective COVID-19 vaccine. The trial enrolled 73 participants in the United States and was randomized, double-blind, and placebo-controlled.
JCXH-221 is being studied as an mRNA-based broadly protective COVID-19 vaccine, according to the Phase 1 clinical trial NCT05743335. The drug is a monoclonal antibody modality and is being evaluated for its safety and immunogenicity in healthy volunteers.