Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JCXH-105 · 1 trial · 3 indications
Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion
Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)
Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)
Adverse events (AEs) including unsolicited AEs, characterized by type, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration to within 30 days following each vaccine administration
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration (JCXH-105 or Shingrix) through follow-up completion
Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration (JCXH-105 or Shingrix) through follow-up completion
| Arm | Type | Description |
|---|---|---|
| Investigational Product | EXPERIMENTAL | Participants randomized to this arm will be given the investigational product (JCXH-105). |
| Active Control | ACTIVE_COMPARATOR | Participants randomized to this arm will be given the FDA approved Shingrix. |
| Name | Type | Description |
|---|---|---|
| JCXH-105 | BIOLOGICAL | As IM injection |
| Active Control (Shingrix) | BIOLOGICAL | As IM injection |
Inclusion Criteria: * Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. * Age: 50 to 69 years of age, inclusive, at screening. * Status: Healthy subjects. Note: Healthy status as defined by the absence of evidence of any clinical...
JCXH-105 is an investigational monoclonal antibody being developed for the prevention of Herpes Zoster (HZ), commonly known as shingles. It is intended for use in adults aged 50 years and older. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
JCXH-105 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its ability to prevent Herpes Zoster (shingles) in adults. As a monoclonal antibody, it is designed to bind to a specific antigen, though the exact target is not publicly available.
JCXH-105 is being developed by Icon Plc, a company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for the prevention of Herpes Zoster (shingles).
JCXH-105 is currently in Phase 1 clinical development. A first-in-human study has been completed, evaluating the drug's safety, tolerability, and immunogenicity in healthy adults aged 50 years and older. The drug is investigational and has not received FDA approval.
JCXH-105 has one completed Phase 1 clinical trial registered under NCT05871541. This first-in-human study enrolled 75 participants in the United States and evaluated the drug as an active-controlled, double-blind, randomized treatment for Herpes Zoster (shingles) in healthy adults aged 50 years and older.
JCXH-105 is a monoclonal antibody, not a vaccine. However, the completed clinical trial NCT05871541 was titled as a study of an SrRNA-based Herpes Zoster Vaccine, suggesting the drug may be a vaccine-like biologic. The exact nature of the product is not fully clarified in available data.