Phase 1 Study of PRX019 in Healthy Adult Volunteers

Phase 1

Recruiting

• Conditions: Healthy Participants Study
• Interventions: Drug: PRX019; Drug: Placebo

• Registration Number: NCT06699680
• Lead Sponsor: Prothena Biosciences Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Status Verified: 2024-11
• Study Start: 2024-11-08
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-01-23
• Study Completion: 2026-01-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PRX019, single dose	PRX019	Specified dose on specified days
PRX019, single dose	Placebo	Specified dose on specified days
PRX019, multiple dose	PRX019	Specified dose on specified days
PRX019, multiple dose	Placebo	Specified dose on specified days

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 6 months
Number of participants with clinical laboratory assessment abnormalities	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Los Alamitos, California, United States