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
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2024
CompletedStudy Start
First participant enrolled
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2026
CompletedMay 14, 2026
May 1, 2026
1.2 years
October 28, 2024
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events
Up to 6 months
Number of participants with clinical laboratory assessment abnormalities
Up to 6 months
Secondary Outcomes (6)
Maximum observed plasma concentration (Cmax)
Up to 6 months
Time to the maximum measured plasma concentration (Tmax)
Up to 6 months
Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)
Up to 6 months
Terminal elimination half-life in plasma (t1/2)
Up to 6 months
Maximum observed plasma concentration at steady state (Cmax,ss)
Up to 6 months
- +1 more secondary outcomes
Study Arms (2)
PRX019, single dose
EXPERIMENTALSpecified dose on specified days
PRX019, multiple dose
EXPERIMENTALSpecified dose on specified days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Los Alamitos, California, 90720, United States
Study Officials
- STUDY DIRECTOR
Chad Swanson
Prothena Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2024
First Posted
November 21, 2024
Study Start
November 8, 2024
Primary Completion
January 16, 2026
Study Completion
January 16, 2026
Last Updated
May 14, 2026
Record last verified: 2026-05