Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LML134 · 1 trial · 1 indication
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
This safety outcome combines the measure of a set of cardiovascular safety parameters extracted from ECGs, 25 hours-Holter ECGs and from vital signs assessments
This safety outcome combines the measure of a set of central nervous system safety parameters extracted from EEGs and neurological examinations
This safety outcome combined the measure of a set of ocular parameters including best corrected visual acuity and other parameters assessed by the mean of slit lamp biomicroscopy and dilated ophthalmoscopy examinations and by optical coherence tomography and electroretinography
This general safety outcome combines the measure of blood laboratory parameters and the outcome of physical examinations
| Arm | Type | Description |
|---|---|---|
| Single dose study part | EXPERIMENTAL | there will be 8 cohorts of healthy volunteers dosed with single doses of LML134 (8 planned dose levels) or with placebo and 2 potential additional cohorts (also dosed with single dose of LML134 or placebo) |
| Multiple dose study part | EXPERIMENTAL | there will be 3 cohorts of healthy volunteers dosed with multiple doses of LML134 (3 planned dose levels) or placebo and one potential additional cohort (also dosed with multiple doses of LML134 or placebo) |
| Name | Type | Description |
|---|---|---|
| LML134 | DRUG | LML134 will be administered first as single doses and then as multiple doses |
| Placebo | DRUG | All study cohorts (except food effect cohort) are placebo controlled |
Inclusion Criteria: * Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests. * Written informed consent must be obtained before any assessment is performed....
LML134 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial assessed its safety and pharmacokinetics in healthy participants, meaning it has not yet been tested for a specific medical condition.
LML134 is being developed by Novartis AG, which trades under the ticker NVS. The company sponsored a first-in-human study of the drug in healthy volunteers. As of the available data, LML134 remains an investigational asset in Phase 1 development.
LML134 is in Phase 1 clinical development. A single first-in-human study has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities. Its safety and pharmacokinetics were evaluated in healthy volunteers.
LML134 has one completed clinical trial, registered as NCT02334449. This was a first-in-human study to assess the safety and pharmacokinetics of LML134 in healthy volunteers. The trial enrolled 133 participants in Germany and was double-blind and controlled, though it was not randomized.
No, LML134 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. The drug is still in clinical development and has not been evaluated for any disease indication. Approval status cannot be confirmed beyond the available trial data.