PRX019 for Healthy Participants

Overseen By Donna-Lee Destouche

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Prothena Biosciences Ltd.

Disqualifiers: Organ dysfunction, Recent investigational drug, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

48 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.

Research Team

Chad Swanson

Principal Investigator

Prothena Biosciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: PRX019, single dose Experimental Treatment 2 Interventions

Specified dose on specified days

Group II: PRX019, multiple dose Experimental Treatment 2 Interventions

Specified dose on specified days

Who Is Running the Clinical Trial?

Prothena Biosciences Ltd.

Lead Sponsor

Trials

8

Recruited

1,200+