A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Intravenous Injection of OP-101 in healthy volunteers.
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
Evaluate the safety and tolerability of OP-101 after single IV doses in healthy subjects by monitoring and documenting all adverse events, which include laboratory test variables.
Time frame: Screening to Day 15.
Pharmacokinetic (PK) Profile Analysis
Determine the PK profile of OP-101 after single IV doses in healthy subjects as determined by plasma concentrations using the PK Concentration Population.
Time frame: Days 1, 2, 3, 4, 8, and 15.
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