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 drug developed by Novartis AG. It has been studied in a first-in-human Phase 1 clinical trial in healthy adult volunteers, rather than in patients with a specific disease. No therapeutic indication for LML134 has been disclosed.
LML134 is made and developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the first-in-human study of the compound. No partner or co-development arrangement for LML134 has been announced.
LML134 is in Phase 1 development. Its only recorded clinical trial was a first-in-human Phase 1 study in healthy volunteers, and that trial is now completed. The drug remains investigational and has not been approved by the FDA for any use.
LML134 has been evaluated in one clinical trial, NCT02334449, titled a first-in-human study to assess the safety and pharmacokinetics of LML134 in healthy volunteers. That Phase 1 trial enrolled 133 participants in Germany and is completed. No active trials of LML134 are currently listed.
The LML134 Phase 1 trial NCT02334449 was a controlled, double-blind study in healthy volunteers aged 18 years and older, including both sexes. It enrolled 133 participants at sites in Germany and assessed safety and pharmacokinetics. The study is completed.