Healthy Participants Study
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
Interventions
DRUGPRX019
Specified dose on specified days
DRUGPlacebo
Placebo
Sponsors
Prothena Biosciences Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to 6 months |
| Number of participants with clinical laboratory assessment abnormalities | Up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss) | Up to 6 months |
Countries
United States
Contacts
STUDY_DIRECTORChad Swanson
Prothena Biosciences
Outcome results
None listed