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OpenTrials
Completed

NCT Number: NCT06699680

Phase 1 Study of PRX019 in Healthy Adult Volunteers

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

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Key information

Conditions

Healthy Participants Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Los Alamitos, California, 90720, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRX019

Drug

Specified dose on specified days

Placebo

Drug

Placebo

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 6 months

  2. Number of participants with clinical laboratory assessment abnormalities

    Time frame: Up to 6 months

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 6 months

  2. Time to the maximum measured plasma concentration (Tmax)

    Time frame: Up to 6 months

  3. Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)

    Time frame: Up to 6 months

  4. Terminal elimination half-life in plasma (t1/2)

    Time frame: Up to 6 months

  5. Maximum observed plasma concentration at steady state (Cmax,ss)

    Time frame: Up to 6 months

  6. Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss)

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Prothena Biosciences Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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