Phase 1 Study of PRX019 in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-08

Study Completion Date

2026-01-23

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Participants Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PRX019, single dose

Specified dose on specified days

Group Type EXPERIMENTAL

PRX019

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Placebo

PRX019, multiple dose

Specified dose on specified days

Group Type EXPERIMENTAL

PRX019

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Placebo

Interventions

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PRX019

Specified dose on specified days

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes