Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LFX453 H1 · 1 trial · 1 indication
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.
Summarized statistics on 5-point scale tolerability scores over 14 days of treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1: LFX453/placebo | EXPERIMENTAL | once daily: LFX453 cream 1 high dose / LFX453 cream 1 low dose /Placebo 1 / LFX453 cream 2 high dose / LFX453 cream 2 low dose / Placebo 2 |
| Part 2 groupA: LFX453/placebo | EXPERIMENTAL | once daily: LFX453 cream 1 / Placebo 1 |
| Part 2 groupB: LFX453/placebo | EXPERIMENTAL | once daily: LFX453 cream 2 / Placebo 2 |
| Part 2 groupC: LFX453/LFX453 | EXPERIMENTAL | once daily: LFX453 cream 1 / LFX453 cream 2 |
| Part 2 groupD: Imiquimod | OTHER | once daily: imiquimod cream |
| Part 3: LFX453/placebo | EXPERIMENTAL | twice daily: LFX453 cream 1 high dose / LFX453 cream 1 low dose /Placebo 1 / LFX453 cream 2 high dose / LFX453 cream 2 low dose / Placebo 2 |
| Name | Type | Description |
|---|---|---|
| LFX453 H1 | DRUG | LFX453 high dose cream 1 |
| LFX453 L1 | DRUG | LFX453 low dose cream 1 |
| LFX453 H2 | DRUG | LFX453 high dose cream 2 |
| LFX453 L2 | DRUG | LFX453 low dose cream 2 |
| Imiquimod | DRUG | Imiquimod cream |
| Placebo 1 | DRUG | Placebo cream 1 |
| Placebo 2 | DRUG | Placebo cream 2 |
Inclusion Criteria: * Healthy male and female subjects of non-childbearing potential, 18 to 65 years of age inclusive (at the time of the screening visit), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screeni...
LFX453 H1 is an investigational small molecule being developed by Novartis AG. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is not approved and remains in clinical trials.
LFX453 H1 is being studied in healthy volunteers as part of a first-in-human trial. The study aims to assess the drug's safety, tolerability, and pharmacokinetics. It is not approved for any specific medical condition and is in early-stage clinical development.
LFX453 H1 is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is in Phase 1 clinical development and is being evaluated in a first-in-human study.
LFX453 H1 is in Phase 1 clinical development. A first-in-human study, NCT02052687, has been completed. This trial enrolled 41 healthy participants in the United Kingdom. The drug is investigational and has not been approved.
LFX453 H1 has one completed clinical trial, NCT02052687, titled "A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453." This Phase 1 study enrolled 41 healthy volunteers in the United Kingdom and was randomized, double-blind, and controlled.