Testing the safety of PRX019 in healthy adults
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending and Multiple Doses of PRX019 in Healthy Adults
This study tests how safe the new drug PRX019 is for healthy adults by comparing it to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Prothena Biosciences Ltd. Industry-sponsored |
| Locations | 1 site (Los Alamitos, California) |
| Trial ID | NCT06699680 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of PRX019 in healthy adult volunteers. Participants will receive either the PRX019 treatment or a placebo to determine how well the drug is tolerated. The study aims to gather data on any potential side effects and overall safety profile of the drug. Healthy individuals will be monitored throughout the study to ensure adherence to protocol requirements.
Who should consider this trial
Good fit: Ideal candidates are healthy adult males and females who meet the study's inclusion criteria.
Not a fit: Patients with any significant health issues or organ dysfunction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of PRX019's safety, paving the way for future studies in patients.
How similar studies have performed: While this study focuses on a specific drug, similar studies assessing the safety of new treatments in healthy volunteers have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period * Participant is willing and able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted * Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer) NOTE: Other protocol-defined inclusion/exclusion criteria apply
Where this trial is running
Los Alamitos, California
- Local Institution — Los Alamitos, California, United States (Recruiting)
Study contacts
- Study coordinator: Daniela Walker
- Email: daniela.walker@prothena.com
- Phone: 650-837-8550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.