Phase 1 Study of PRX019 in Healthy Adult Volunteers

Description

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

Conditions

Healthy Participants Study

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Study Overview

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Study Details

Study overview

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

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

Phase 1 Study of PRX019 in Healthy Adult Volunteers

Condition
Healthy Participants Study
Intervention / Treatment

-

Contacts and Locations

Los Alamitos

Local Institution, Los Alamitos, California, United States, 90720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Prothena Biosciences Ltd.,

Chad Swanson, STUDY_DIRECTOR, Prothena Biosciences

Study Record Dates

2026-01-23