Recruiting
Phase 1

JZP269

Sponsor:

Jazz Pharmaceuticals

Code:

NCT07813663

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

JZP269

Placebo

Study Details

Brief summary:

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

Conditions

Healthy Participants

Study ID

NCT07813663

Start date

Sep 22, 2026

Status verified date

Nov, 2026

Completion date

Feb 27, 2027

Anticipated

Primary completion date

Feb 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JZP269

Participants will receive JZP269.

placebo comparator: Placebo

Participants will receive a matching placebo.

Interventions

JZP269

Administered as described.

Placebo

Administered as described.

Primary outcome measure

  • Number of Participants Reporting Treatment-emergent Adverse Events [ Time Frame: Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit) ]
  • Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269 [ Time Frame: Predose up to 48 hours postdose ]
  • Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269 [ Time Frame: Predose up to 48 hours postdose ]
  • Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269 [ Time Frame: Predose up to 48 hours postdose ]
  • Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269 [ Time Frame: Predose up to 48 hours postdose ]
  • Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269 [ Time Frame: Predose up to 48 hours postdose ]
  • Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269 [ Time Frame: Predose up to 48 hours postdose ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure & Transparency

215-832-3750ClinicalTrialDisclosure@JazzPharma.com

Locations

Celerion

Recruiting

Lincoln, Nebraska, United States, 68502

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • Healthy Participants
  • JZP269

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.