First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers

A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study, to Assess the Safety, Tolerability and Pharmacokinetics of LML134 in Healthy Volunteers

Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers

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.
• Able to communicate well with the Investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

• History or presence of epilepsy or of seizures or convulsions of any kind.
• Any clinically relevant abnormalities identified in the resting EEG during screening, or pre-ictal signs or other clinically relevant abnormalities in the hyperventilation or intermittent photic stimulation EEG during screening.
• History of head trauma leading to clinically significant symptoms in the past two years.
• Applies only to subjects enrolled in Part 2 MAD. Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
• Significant illness including any clinically significant infectious disease which has not resolved within two (2) weeks prior to initial dosing.
• History or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (infection, vaccination), of any etiology as indicated by clinically significantly abnormal values of any of the following hematologic parameters: thrombocyte, RBC count, total WBC count and differentials presented as % of total white blood cell count and as absolute concentrations.
• History or presence of any thyroid disease as indicated by any clinically relevant abnormality on thyroid stimulating hormone test (TSH).
• History or presence of any chronic eye disease other than refractive error, strabismic amblyopia, or anisometropic amblyopia.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.