A Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Injection of Quarterly Risperidone (QUAR) for Different Formulations and Dose Strengths in Participants With Schizophrenia (QUARTZ Study)

ROV-QUAR-2023-01

This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia.

2023-09-26

2026-05-01

2026-05-01

Recruiting

Early phase I

100

Inclusion Criteria: * Capable of providing informed consent. * Male or female aged ≥ 18 years to \< 65 years with BMI ≥17.0 to ≤35.0 kg/m2 * Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria. * Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment * currently taking oral risperidone as maintenance therapy * Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S) * If a sexually active female of childbearing potential, using a medically accepted method of birth control. Exclusion Criteria: * Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations * If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child. * History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia. * The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment * Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use. * In the investigator's opinion, at imminent risk of committing self-harm or harm to others. * Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide). * Receipt study drug in another investigational study in the last 90 days. * Current participation in any other clinical trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-03-12