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
Prothena Biosciences Ltd.
Summary
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- 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 conducte…
Interventions
- DrugPRX019
Specified dose on specified days
- DrugPlacebo
Placebo
Location
- Local InstitutionLos Alamitos, California