Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults
Completed
LB Pharmaceuticals Inc.
Phase 1
A Single Ascending Dose (SAD; Part A) and Multiple Ascending Dose (MAD; Part B) Phase 1 Study
of LB-102 N-Methyl amisulpride) in healthy volunteers. The primary objective is to evaluate
the safety and the tolerability of a single oral dose (SAD) and multiple oral doses (MAD) of
LB-102 as compared to placebo. The secondary objectives are to evaluate the pharmacokinetics
(PK) and pharmacodynamics (PD) of LB-102.
Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers
Active, not recruiting
Washington University School of Medicine
Phase 1
This is an open label study in 4 cohort of 4 healthy volunteers each designed to evaluate the
dopamine receptor occupancy of LB-102 at various doses and timepoints.
Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers
Active, not recruiting
LB Pharmaceuticals Inc.
Phase 1
This is an open label study in 4 cohort of 4 healthy volunteers each designed to evaluate the
dopamine receptor occupancy of LB-102 at various doses and timepoints.
Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia
Recruiting
LB Pharmaceuticals Inc.
Phase 2
This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study
to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely
exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely
exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from
Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo
at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S,
safety and tolerability, and pharmacokinetics.
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