Phase 1 Study of PRX019 in Healthy Adult Volunteers

Prothena

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants Study

Treatments: Drug: PRX019; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06699680

PRX019-101

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

PRX019, single dose

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: Placebo

Drug: PRX019

PRX019, multiple dose

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: Placebo

Drug: PRX019