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 drug developed by Novartis AG. It has been studied in a first-in-human Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.
LFX453 H1 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the first-in-human study of the compound, which was conducted in the United Kingdom.
LFX453 H1 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.
LFX453 H1 has been evaluated in one clinical trial, NCT02052687, titled a first-in-human study to evaluate the safety, tolerability and pharmacokinetics of LFX453. The Phase 1 trial enrolled 41 healthy volunteers in the United Kingdom and has been completed.
The Phase 1 trial NCT02052687 was a randomized, double-blind, controlled study of LFX453 in healthy adult volunteers aged 18 years and older. It enrolled 41 participants of all sexes in the United Kingdom and assessed safety, tolerability and pharmacokinetics. The study has been completed.