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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06699680