A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers
Abstract
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).
Primary outcome: Safety endpoint - Evaluation of the Incidence, severity, and relationship of AEs/SAEs (or ADEs/SADEs) (including withdrawals due to AEs (or ADEs)).; Safety endpoint - Change from baseline in physical examination findings (Full); Safety endpoint - Change from baseline in physical examination findings (symptom directed); Safety endpoint - Change from baseline in vital signs (including changes from baseline in SpO2).; Safety endpoint - Change from baseline in vital signs (including changes from baseline in blood pressure).; Safety endpoint - Change from baseline in vital signs (including changes from baseline in heart rate).; Safety endpoint - Change from baseline in vital signs (including changes from baseline in respiration rate).; Safety endpoint - Change from baseline in vital signs (including changes from baseline in body temperature).; Safety endpoint - Changes from baseline in lung spirometry.; Safety endpoint - Change from baseline in ECG parameters of heart rate; Safety endpoint - Change from baseline in ECG parameters of PR interval, QRS interval, and QT interval; Safety endpoint - Change from baseline in hematocrit values; Safety endpoint - Change from baseline in hemoglobin values; Safety endpoint - Change from baseline in Red Blood Cell (RBC) indices; Safety endpoint…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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