MedTrace Logo

A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers

NCT05033444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-04

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers

Conditions

  • Traumatic Brain Injury (TBI)

Interventions

DRUG

PRV-002

SAD portion: Eligible participants will be randomized to receive a single ascending dose of PRV-002 on study Day 1. Dose escalation will be conducted in a total of 3 cohorts. Within each cohort, 6 participants will be randomized to receive a single dose of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.533 mg/kg (based on a 60kg participant) will be investigated. MAD portion: Eligible participants will be randomized to receive a multiple (one dose per day for 5 consecutive days). Dose escalation will be conducted in a total of 2 cohorts. Within each cohort, 6 participants will be randomized to receive of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.133 to 0.266 mg/kg (based on a 60kg participant) will be investigated.

DRUG

Placebo

Placebo used is hydroxypropyl beta cyclodextrin (HPβCD)

Sponsors & Collaborators

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • Odyssey Group International, Inc.

    lead INDUSTRY

Principal Investigators

  • Philip Ryan, Dr. · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2022-10-01
Completion
2024-09-13
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033444 on ClinicalTrials.gov