RECRUITING

Phase 1 Study of PRX019 in Healthy Adult Volunteers

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-08

Study Completion:2026-01-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06699680

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

Daniela Walker

CONTACT

650-837-8550

daniela.walker@prothena.com

Donna-Lee Destouche

CONTACT

650-837-8550

donna-lee.destouche@prothena.com

Principal Investigator

Chad Swanson

STUDY_DIRECTOR

Prothena Biosciences

Study Locations (Sites)

Local Institution

Los Alamitos, California, 90720

United States

Collaborators and Investigators

Sponsor: Prothena Biosciences Ltd.

Chad Swanson, STUDY_DIRECTOR, Prothena Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-08

Study Completion Date2026-01-23

Study Record Updates

Study Start Date2024-11-08

Study Completion Date2026-01-23

Terms related to this study

Additional Relevant MeSH Terms

Healthy Participants Study