Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to examine the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. The primary objective of the study is to assess the efficacy of LB-102 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores at day 28 in approximately 350 adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in CGI-S, PANSS subscale and Marder Factor scores, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia. The duration of treatment of the study is 28 days (4 weeks). Patients in this study will be randomized 3:3:3:1 to receive either: placebo, 50 mg QD LB-102, 75 mg QD LB-102, or 100 mg QD LB-102; that is, \~105 patients will get placebo, \~105 will get 50 mg LB-102 QD, \~105 will get 75 mg LB-102 QD, \~35 will get 100 mg LB-102 QD. LB-102 will be dosed orally once a day. Pharmacokinetic data will be measured for the first 60 patients in this study.