This is a Phase 1, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, 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.
Official registry: https://clinicaltrials.gov/study/NCT07923097 · Rapport Therapeutics Inc. · enrollment listed as 60
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are RAP-219 or Placebo. The registry lists allocation as randomized. This is a Phase 1, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, 5-cohort study evaluating the pharmacokinetics (PK), safety, and tolerability of RAP-219-LAI in healthy participants aged 18 to 65 years.
They plan to enroll about 60 people at Adelaide. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: RAP-219 or Placebo
Primary outcome (registry wording): Maximum Plasma Concentration (Cmax)
Rapport Medical
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment.
NCT00060541 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery.
NCT01273129 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.
NCT01793168 · Official ClinicalTrials.gov record · Sanford Health
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary