Schizophrenia Clinical Trial
Official title:
A Phase 1b/2a, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APN1125 in Subjects With Schizophrenia
The purpose of this study in patients with schizophrenia is to evaluate the safety, tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with placebo when administered as repeated daily oral doses.
The purpose of this study is to evaluate the safety profile, tolerability and
pharmacokinetics (PK) of APN1125 following 14 days of once-daily oral dosing in subjects
with schizophrenia on stable second-generation antipsychotic therapy.
This is a randomized, double-blind, 2-week, multiple ascending dose study of APN1125. This
study will enroll up to three sequential cohorts of subjects diagnosed with schizophrenia,
each randomly assigned to receive one of three doses (low, medium, or high) of APN1125 or
matching placebo. Following admission to an Early Phase Clinical Unit (EPCU), APN1125 will
be administered once daily for 2 weeks. All subjects will remain confined to the EPCU for a
total of 20 days, consisting of admission, dosing and observation periods.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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