A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
Start Date
8/4/2025
Completion Date
2/1/2028
Summary
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 268 participants will be enrolled across roughly 32 sites in the United States. Participants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. Participants will be followed for 30 days after the last dose of the study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Emraclidine
Placebo
Conditions
Locations
Woodland International Research Group /ID# 275747
Little Rock, Arkansas 72211
United States
Collaborative Neuroscience Research - Garden Grove /ID# 273005
Garden Grove, California 92845
United States
California Clinical Trials Medical Group - Parexel /ID# 275751
Glendale, California 91206
United States
Cbh Health - Gaithersburg /ID# 272932
Gaithersburg, Maryland 20877
United States
Cenexel Hassman Research Institute (Hri) /ID# 276128
Marlton, New Jersey 08053
United States
Community Clinical Research - Austin - Cross Park Drive /ID# 272977
Austin, Texas 78754
United States
Pillar Clinical Research - Richardson /ID# 275715
Richardson, Texas 75080
United States