Approval Probability
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LTB-NG6 · 1 trial · 1 indication
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: \- Percentage of participants reporting each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants reporting any adverse event (AE) following each injection * Percentage of participants reporting each severity level (Grade 1-4) of solicited local, systemic and unsolicited AEs following each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants with unsolicited AEs. * Percentage of participants with serious adverse events (SAEs) following each injection. * Percentage of participants with medically attended adverse events (MAAEs) following each injection.
To evaluate the immunogenicity of different doses of LTB-NG6 to identify the preferred dose(s). Serum IgG geometric mean titers (GMTs) against each of the N. gonorrhoeae antigens included in LTB-NG6 summarized by treatment group
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants receive 2 administrations of Sodium chloride 0.9% |
| Dose 1 | EXPERIMENTAL | Participants receive 2 Dose 1 administrations of the investigational product |
| Dose 2 | EXPERIMENTAL | Participants receive 2 Dose 2 administrations of the investigational product |
| Dose 3 | EXPERIMENTAL | Participants receive 2 Dose 3 administrations of the investigational product |
| Dose 4 | EXPERIMENTAL | Participants receive 2 Dose 4 administrations of the investigational product |
| Dose 5 | EXPERIMENTAL | Participants receive 2 Dose 5 administrations of the investigational product |
| Name | Type | Description |
|---|---|---|
| LTB-NG6 | BIOLOGICAL | LTB-NG6 administrated at 5 different doses |
| Sodium Chloride 0.9% | OTHER | sodium chloride 0.9% used as a diluent in LTB-NG6 and as a placebo |
Inclusion Criteria: 1. Aged 18-50 years (inclusive) at the time of the first injection 2. Good and stable general health, determined by medical history, laboratory findings and physical examination as judged by the Investigator before receiving the first injection. 3. Willingness and ability to com...
LTB-NG6 is an investigational monoclonal antibody being developed for the prevention of Neisseria gonorrhea infection. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use and is still being studied for safety and immunogenicity in healthy volunteers.
LTB-NG6 is a monoclonal antibody designed to target Neisseria gonorrhea, the bacterium that causes gonorrhea. As a monoclonal antibody, it is intended to bind to specific components of the bacteria to help prevent infection, though the precise molecular target has not been disclosed.
LTB-NG6 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the stock exchange under the ticker NVO. The company is conducting a Phase 1 clinical trial to evaluate the safety and immunogenicity of this investigational antibody.
LTB-NG6 is in Phase 1 clinical development. It is an investigational drug, meaning it is not FDA approved and is still being tested in clinical trials. The current Phase 1 study is recruiting participants to assess the safety and immune response of the antibody in healthy volunteers.
LTB-NG6 is being studied in a Phase 1 clinical trial registered as NCT07758972, titled 'Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine.' This randomized, double-blind, placebo-controlled trial is recruiting 142 healthy volunteers in Germany, with participants aged 18 years and older.
LTB-NG6 is a monoclonal antibody, not a vaccine. However, it is being studied in a clinical trial titled 'Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine,' which may involve multiple components. The trial is evaluating the safety and immune response of the investigational product in healthy volunteers.