RecruitingPhase 1NCT06699680

Phase 1 Study of PRX019 in Healthy Adult Volunteers

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


Sponsor

Prothena Biosciences Ltd.

Enrollment

48 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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)

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Interventions

DRUGPRX019

Specified dose on specified days

DRUGPlacebo

Placebo


Locations(1)

Local Institution

Los Alamitos, California, United States

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NCT06699680


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