48 Participants Needed

PRX019 for Healthy Participants

DW
DD
Overseen ByDonna-Lee Destouche
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Prothena Biosciences Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of PRX019, a new treatment, in healthy adults. Researchers will assess how the body handles PRX019, beginning with different dosing schedules. Participants should be healthy individuals without significant health issues or recent involvement in other drug studies. This trial offers an opportunity to contribute to medical research for those who meet these criteria.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking certain medications might affect eligibility. Please consult with the study team for specific guidance.

Is there any evidence suggesting that PRX019 is likely to be safe for humans?

Research has shown that PRX019 has undergone safety testing in people. Early studies indicate that this treatment is generally safe and well-tolerated. Most reported side effects were mild or moderate, similar to those experienced with a placebo (a fake treatment with no active drug). As PRX019 remains in early testing, the primary goal is to assess its safety in people. This trial will gather more information about any possible side effects when administered in single or multiple doses.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about PRX019 because it offers a novel approach to treatment, focusing on its unique mechanism of action. Unlike current treatments, which may target broader pathways, PRX019 is designed to specifically target and modulate key biological processes more precisely. This specificity could potentially lead to more effective outcomes with fewer side effects. Additionally, the study includes both single and multiple dose regimens, providing flexibility and potentially improving patient adherence and outcomes.

What evidence suggests that PRX019 could be effective?

Research on PRX019 remains in the early stages. This trial tests its safety and tolerability in healthy adults. Participants receive either a single dose or multiple doses of PRX019. Current studies focus on ensuring its safety for use, rather than its effectiveness for a specific health problem. As PRX019 is just beginning to be studied, information on its efficacy is limited. Ensuring safety is a crucial first step before exploring its potential benefits for specific health issues in the future.13678

Who Is on the Research Team?

CS

Chad Swanson

Principal Investigator

Prothena Biosciences

Are You a Good Fit for This Trial?

This trial is for healthy adults who meet specific health standards. The exact inclusion and exclusion criteria are not provided, but typically participants must have no significant medical conditions and be within a certain age range.

Inclusion Criteria

I am considered healthy based on my recent medical exams and tests.
Participant is willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

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)
My health tests show I might not be in the normal range for my area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple doses of PRX019 to assess safety and tolerability

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PRX019
Trial Overview The study is testing PRX019 against a placebo to see how safe it is and how well people can tolerate it. This phase 1 trial will likely start with small doses of PRX019 to monitor reactions before increasing amounts.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: PRX019, single doseExperimental Treatment2 Interventions
Group II: PRX019, multiple doseExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prothena Biosciences Ltd.

Lead Sponsor

Trials
8
Recruited
1,200+

Citations

Phase 1 Study of PRX019 in Healthy Adult VolunteersThe purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
Phase 1 Study of PRX019 in Healthy Adult VolunteersThe purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
CORPORATE OVERVIEW1 Coramitug potential milestone could be achieved after prespecified enrollment criteria are met in the Phase 3 clinical trial. PRX019 potential ...
prta-20241231This is a randomized, double-blind, placebo-controlled, global, Phase 2 clinical trial designed to evaluate the efficacy, safety, and tolerability of BMS-986446 ...
Roche And Prothena: Why Moving On Makes Sense40 healthy participants were randomized across cohorts, either treated or given placebo. The study demonstrated the ability of the antibody ...
Clinical Trials & Expanded Access PolicyBristol Myers Squibb obtained the exclusive global license for PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target, in 2024.
CORPORATE OVERVIEWPRX019 potential milestone could be achieved at time of decision to further develop PRX019 expected in 2026. Coramitug. ATTR-CM. Ph 2 Trial.
PRX-019 - Drug Targets, Indications, PatentsA Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Immunogenicity, ...
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