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LML134

Phase 1

Healthy Volunteers | Small molecule | Other |Novartis AG|Last Updated: Oct 27, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
Double-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment133
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02334449First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy VolunteersPHASE1 COMPLETED 133 — — Feb 1, 2015Feb 1, 2016Oct 27, 20161 Germany
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Study Endpoints
Primary Endpoints
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Starting about 24 hours before dosing and continued until about 7-14 days after last dose

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.

Cardiovascular safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Starting about 24 hours before dosing and continued until about 7-14 days after last dose

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

Central nervous system safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Starting about 24 hours before dosing and continued until about 7-14 days after last dose

This safety outcome combines the measure of a set of central nervous system safety parameters extracted from EEGs and neurological examinations

Ocular safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Starting about 24 hours before dosing and continued until about 7-14 days after last dose

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

General safety assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Starting about 24 hours before dosing and continued until about 7-14 days after last dose

This general safety outcome combines the measure of blood laboratory parameters and the outcome of physical examinations

Secondary Endpoints
Pharmacokinetics (PK) of LML134: time to reach the maximum concentration after a single drug administration (Tmax) in Part 1 and in Part 3
Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: Observed maximum serum concentration following single drug administration (Cmax) in Part 1 and Part 3
Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
PK of LML134: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) in Part 1 and Part 3
Starting 1hour prior to dosing on Day 1 and until 72 hours after dosing (Day 4)
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Study Design & Arms
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single dose study partEXPERIMENTALthere 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 partEXPERIMENTALthere 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)
Interventions
NameTypeDescription
LML134DRUGLML134 will be administered first as single doses and then as multiple doses
PlaceboDRUGAll study cohorts (except food effect cohort) are placebo controlled
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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....

Countries:Germany
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