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
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.
Studieöversikt
Detaljerad beskrivning
Participants will be randomized to receive a single dose of RAP-219-long acting injectable (LAI) (RAP-219-LAI) nanosuspension or placebo (Cohort 1, Cohort 2, Cohort 3, and Cohort 4), or 2 doses of RAP-219-LAI or placebo (Cohort 5) 28 days apart. A starting dose of 2.5 mg for Cohort 1 was chosen based on reviews of the preclinical data, clinical trials data and PK modelling and simulation. A sentinel group of 2 participants will be dosed and monitored for 24 hours. The rest of that cohort (8) will be dosed if there are no safety concerns noted with the sentinel group. A dose escalation committee (DEC) will review the safety and available PK data for cohort 1 and make a determination on the dose for Cohort 2. The DEC will review the data for subsequent cohorts and advise on does as well as study progression based on the emerging and cumulative safety and PK data.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Rapport Medical
- Telefonnummer: 857 323 9048
- E-post: RAP-219-FOS@rapportrx.com
Studieorter
-
-
-
Adelaide, Australien
- Rekrytering
- CMAX Clinical Research
-
Kontakt:
- Dr. Thomas Polasek
- Telefonnummer: +61 458 162 715
- E-post: Thomas.Polasek@cmax.com.au
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the course of the study
- Skin conditions affecting abdominal injection site or any condition or characteristic that may prevent assessment of injection site reactions (ISRs)
- Inadequate venous access or unsuitable veins for venipuncture
- 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.
- 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
- Recent history or current substance abuse
- 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
- 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
- Any non-negative serology results for hepatitis B surface antigen, hepatitis C antibody, or HIV antigen and antibody.
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Kohort 1
|
Route of Administration: Subcutaneous injection |
|
Experimentell: Kohort 2
|
Route of Administration: Subcutaneous injection |
|
Experimentell: Kohort 3
|
Route of Administration: Subcutaneous injection |
|
Experimentell: Kohort 4
|
Route of Administration: Subcutaneous injection |
|
Experimentell: Kohort 5
|
Route of Administration: Subcutaneous injection |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Maximum Plasma Concentration (Cmax)
Tidsram: Up to 84 days
|
Up to 84 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Safety: Adverse Events (AEs)
Tidsram: Up to 112 days
|
Up to 112 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RAP-219-LAI-101
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .