Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LTB-SA7 · 1 trial · 1 indication
Occurrence and severity of solicited local and systemic AEs during 7 days after each dose (i.e., day of vaccination and the 6 subsequent days) in all participants by intervention group.
Occurrence, severity, and relationship to vaccination of unsolicited AEs during 28 days after each dose (i.e., day of injection and the 27 subsequent days) in all participants by intervention group.
Occurrence, severity, and relationship to vaccination of SAEs in all participants during the trial duration by intervention group.
Serum IgG antibody geometric mean titers (GMT) against each of the 7 toxoids present in the LTB-SA7 vaccine in serum samples collected 4 weeks after the 1st vaccination (Visit 4 \[Day 29\]) by intervention group to identify preferred dose(s).
| Arm | Type | Description |
|---|---|---|
| LTB-SA7 low dose, 1 vaccination | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo. |
| LTB-SA7 low dose, 2 vaccinations | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart. |
| LTB-SA7 medium dose, 1 vaccination | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo. |
| LTB-SA7 medium dose, 2 vaccinations | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart. |
| LTB-SA7 high dose, 1 vaccination | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered once, 1 month later participant receives a placebo. |
| LTB-SA7 high dose, 2 vaccinations | EXPERIMENTAL | The candidate toxoid vaccine (LTB-SA7) is administered twice, 1 month apart. |
| Placebo | PLACEBO_COMPARATOR | Participant receives placebo twice, 1 month apart. |
| Name | Type | Description |
|---|---|---|
| LTB-SA7 | BIOLOGICAL | LTB-SA7 is a toxoid based vaccine consisting of five components including seven toxoids formulated with Alhydrogel. |
| Placebo | BIOLOGICAL | Sodium Phosphate with Sodium Chloride |
Inclusion Criteria: 1. Good general health by medical history, laboratory findings and physical examination as judged by the investigator before receiving the first injection. 2. Participant who is willing and able to comply with the requirements of the protocol (e.g., completion of the diary forms...
LTB-SA7 is an investigational monoclonal antibody being developed for the prevention of Staphylococcus (S.) aureus infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
LTB-SA7 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 1 clinical development.
LTB-SA7 is in Phase 1 clinical development. A first-in-human trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency.
LTB-SA7 has one completed clinical trial, NCT06719219, which was a first-in-human study assessing safety and immunogenicity against Staphylococcus aureus. The trial enrolled 129 participants in the United States and was randomized, double-blind, and placebo-controlled.
LTB-SA7 is described as a monoclonal antibody, though its clinical trial title refers to it as a vaccine against Staphylococcus aureus. The completed Phase 1 trial assessed safety and immunogenicity in healthy volunteers.