NCT07923097RecruitingPhase 1
Study Designed to Evaluate the Safety, Tolerability, and PK of RAP-219 Formulated as an Long Acting Injectable.
A Phase 1, Double-blind, Placebo-controlled, Single- and Multiple-dose Study of the Safety, Tolerability, and Pharmacokinetics of RAP-219 Administered as a Long-acting Injectable to Healthy Participants
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
This is a Phase 1, double-blind, placebo-controlled, 5-cohort study evaluating the pharmacokinetics (PK), safety, and tolerability of RAP-219-LAI in healthy participants aged 18 to 65 years. Assessment of up to four single-dose cohorts will characterize the PK profile of up to four ascending dose levels and evaluate dose proportionality. One multiple-dose cohort will characterize the accumulation profile of RAP-219-LAI. The study includes a Screening Period of up to 28 days (Day -28 to Day -1) for participants in all cohorts. Cohorts 1, 2, 3, and 4 will include admission on Day -1, a single dosing day (Day 1), a 28-day inpatient and outpatient Treatment Period (Day 1 to Day 28), and a 28-day Follow-up Period (Day 29 to Day 56). Cohort 5 will include admission on Day -1 and Day 28, two dosing days (Day 1 and Day 29), a 56-day inpatient and outpatient Treatment Period (Day 1 to Day 56), and a 28-day Follow-up Period (Day 57 to Day 84). Up to 60 participants are planned to be enrolled in this study, with 12 participants per cohort randomized in a 3:1 ratio to receive RAP-219-LAI or placebo.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Rapport Therapeutics Inc.
- Diseases
- Epilepsy
- NCT number
- NCT07923097
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From Nov 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Donated blood or experienced significant blood loss (greater than or equals to 450 millilitres) within 12 weeks, donated bone marrow or peripheral stem cells within 90 days, or donated plasma within 4 weeks prior to Day 1.
- Consumption of liquids or foods containing Seville oranges, grapefruit, lime, pomegranate, or star fruit from 7 days prior to Day 1, or poppy seed from 3 days prior to Day 1 (all cohorts)
- Unable or unwilling to refrain from strenuous exercise from 3 days prior to Day 1 and during the inpatient periods through the end of the study
- Any surgical procedure within 3 months prior to Screening from which a full recovery was not made and/or with sequelae that may impact study procedures/outcomes and/or safety, as judged by the PI or delegate
Other illness
- Skin conditions affecting abdominal injection site or any condition or characteristic that may prevent assessment of injection site reactions (ISRs)
- History of malignancy, with the exception of non-melanoma skin cancer or cancer curatively treated greater than or equals to 5 years prior to Screening without evidence of recurrence
- Any non-negative serology results for hepatitis B surface antigen, hepatitis C antibody, or HIV antigen and antibody.
Lab values
- History of any illness, any medical or psychiatric condition, or laboratory abnormality that, in the opinion of the PI or delegate, might prevent the participant from completing the study, pose a risk to the participant, or confound the results of the study
Other
- Pregnant or breastfeeding, or intending to become pregnant during the course of the study
- Inadequate venous access or unsuitable veins for venipuncture
- Recent history or current substance abuse
Who the study is looking for
- Able and willing to provide written informed consent to participate in the study and comply with all aspects of the protocol
- Age 18 to 65 years, inclusive, at Screening
- Medically healthy, with no current medical or psychiatric conditions, or those that the participant has been diagnosed with or received treatment for in the past 1 year, or clinically significant abnormalities, as determined by the PI or delegate based on the participant's medical history, physical examination, vital signs, ECG, and laboratory evaluations
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMAX Clinical Research Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.