NCT07813663 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 212 participants in total. It began in 2026-09-22 with a primary completion date of 2027-02-27.

Brief Summary

This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.

Eligibility Criteria

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is 18 to 55 years of age, inclusive, at the time of signing the informed consent. 2. Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac/blood pressure monitoring. 3. Has a body weight of at least 45 kg and BMI within the range of 18.5 to 30 kg/m\^2 (inclusive). Participants are excluded from the study if any of the following criteria apply: 1. Has a history of or presence of clinically significant medical illness as specified in the protocol. 2. Has a family history (first degree relative) of torsades de pointes, premature sudden death, long QT syndrome, or clinically significant cardiac conduction disorders. 3. Has a known or suspected history of schizophrenia or other psychotic illness or a history of severe personality disorder or other significant psychiatric disorder. 4. Has a history (within 5 past years) or presence of diagnosis of alcohol abuse or alcohol use disorder, substance abuse or substance use disorder, or known drug dependence or is seeking treatment for an alcohol or substance abuse related disorder. 5. Has a current diagnosis of or is receiving treatment for depression or has a history (within past 5 years) of clinically significant major depressive episode. 6. Has a history of suicide attempt, a current suicidal risk as determined from history, or the presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS (within the past 24 months). 7. In participants where cerebrospinal fluid will be collected, any contraindications to lumbar puncture including increased intracranial pressure, conditions that may lead to brain herniation, a history of degenerative spine disease or lumbar spinal stenosis, a history of lumbar surgery, or prior history of adverse experience with lumbar puncture (eg, headache). 8. Has a clinically significant ECG abnormality per investigator assessment or an average PR \> 200 msec, average QRS \> 110 msec, average QTcF \> 440 msec for men and women, or flattened or difficult to distinguish T-waves. 9. Has a resting supine systolic blood pressure \> 140 mmHg or \< 90 mmHg, resting supine diastolic blood pressure \> 90 mmHg or \< 50 mmHg, or resting supine heart rate \> 100 bpm or \< 40 bpm at screening or check-in.

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