Phase 1 Study of PRX019 in Healthy Adult Volunteers

NCT06699680 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRX019-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants Study

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

Study Arms (2)

PRX019, single dose

EXPERIMENTAL

Specified dose on specified days

Drug: PRX019; Drug: Placebo

PRX019, multiple dose

EXPERIMENTAL

Specified dose on specified days

Drug: PRX019; Drug: Placebo

Interventions

PRX019 DRUG

Specified dose on specified days

PRX019, multiple dose; PRX019, single dose

Placebo DRUG

Placebo

PRX019, multiple dose; PRX019, single dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Prothena Biosciences Ltd.: lead

Study Sites (1)

Local Institution

Los Alamitos, California, 90720, United States

RECRUITING

Study Officials

• Chad Swanson

  Prothena Biosciences

  STUDY DIRECTOR

Central Study Contacts

Daniela Walker

CONTACT

650-837-8550; daniela.walker@prothena.com

Donna-Lee Destouche

CONTACT

650-837-8550; donna-lee.destouche@prothena.com

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 23, 2026
• Study Completion: January 23, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)