RAP-219 long-acting injectable safety and PK study in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, double-blind, placebo-controlled study designed to characterize the pharmacokinetics, safety, and tolerability of RAP-219-LAI in up to 60 healthy participants aged 18–65. The study uses single-dose cohorts to evaluate PK across four ascending doses and a multiple-dose cohort to examine accumulation, with a sentinel group and dose-escalation decisions by a safety and PK review committee. Participants undergo screening, dosing, a 28-day inpatient/outpatient treatment period, and follow-up, with one cohort receiving two doses 28 days apart. The intervention compares RAP-219-LAI with placebo across cohorts.

Why it matters

Who can join: the full rules

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

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

Where it's running

• CMAX Clinical Research
  Adelaide, Australia Recruiting

Study contacts

• Study coordinator: Rapport Medical
• Email: RAP-219-FOS@rapportrx.com
• Phone: 857 323 9048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.