Phase 1 Study of PRX019 in Healthy Adult Volunteers

Last updated: November 19, 2024
Sponsor: Prothena Biosciences Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

PRX019

Clinical Study ID

NCT06699680
PRX019-101
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants who are healthy as determined by the investigator basedon review of medical history, physical examination, and clinical laboratory testsobtained during the screening period

  • Participant is willing and able to adhere to the study visit schedule and otherprotocol requirements

Exclusion

Exclusion Criteria:

  • Evidence of organ dysfunction or any clinically significant deviation from normal inphysical examination, vital signs, or clinical laboratory tests beyond what isconsistent with a healthy population in the region in which the study is conducted

  • Participant was exposed to an investigational drug (new chemical entity) within 90days preceding the first dose administration, or within 7 times the eliminationhalf-life, if known (whichever is longer)

NOTE: Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 08, 2024
Estimated Completion Date:
January 23, 2026

Connect with a study center

  • Local Institution

    Los Alamitos, California 90720
    United States

    Active - Recruiting

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