NCT05033444

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Odyssey Group International, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of different dose levels of PRV-002 in Healthy Volunteers. The study will evaluate 3 dose levels of the investigational product, PRV-002, in 5 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. Cohorts 1 - 3 will receive a single dose of PRV-002 or placebo. Cohorts will receive one dose of PRV-002 or placebo per day for 5 consecutive days.

Conditions

• Traumatic Brain Injury (TBI)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-10-01
• Completion: 2024-09-13
• First posted: 2021-09-02
• Last updated: 2024-11-04

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study