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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07923097




Registration number
Help: Registration number
NCT07923097
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
16/10/2026
Date registered
Help: Date registered
6/11/2026
Date last updated
Help: Date last updated
6/11/2026

Titles & IDs
Public title
Study Designed to Evaluate the Safety, Tolerability, and PK of RAP-219 Formulated as an Long Acting Injectable.
Scientific title
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
Additional trial identifiers [1] 0 0
RAP-219-LAI-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - RAP-219 or Placebo

Experimental: Cohort 1 -

Experimental: Cohort 2 -

Experimental: Cohort 3 -

Experimental: Cohort 4 -

Experimental: Cohort 5 -


Treatment: Drugs: RAP-219 or Placebo
Route of Administration: Subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Plasma Concentration (Cmax)
Timepoint [1] 0 0
Up to 84 days
Secondary outcome [1] 0 0
Safety: Adverse Events (AEs)
Timepoint [1] 0 0
Up to 112 days

Eligibility
Key inclusion criteria
1. Able and willing to provide written informed consent to participate in the study and comply with all aspects of the protocol
2. Age 18 to 65 years, inclusive, at Screening
3. 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. Pregnant or breastfeeding, or intending to become pregnant during the course of the study
2. Skin conditions affecting abdominal injection site or any condition or characteristic that may prevent assessment of injection site reactions (ISRs)
3. Inadequate venous access or unsuitable veins for venipuncture
4. 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.
5. 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
6. Recent history or current substance abuse
7. 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)
8. 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
9. 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
10. Any non-negative serology results for hepatitis B surface antigen, hepatitis C antibody, or HIV antigen and antibody.
11. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/10/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Rapport Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rapport Medical
Address 0 0
Country 0 0
Phone 0 0
857 323 9048
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07923097