The objectives of this trial are: 1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers 2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.
The first in human study is intended to evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
32
Quotient Sciences
Miami, Florida, United States
Pharmacokinetic (PK) Parameter Cmax
Cmax = maximum observed blood plasma concentration of RVP-001
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter Tmax
tmax = time of maximum observed plasma concentration of RVP-001
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter t1/2
t1/2 = terminal elimination half-life of RVP-001
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter Cl
Cl = total body clearance calculated after a single IV administration of RVP-001
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
PK Parameter Vd
Vd = volume of distribution calculated after a single IV administration of RVP-001
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
% RVP-001 Dose Excreted
mean % of RVP-001 excreted from urine from 0 -120 hours post dose
Time frame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.