Primary Objective • To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives * To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429 * To characterize the pharmacokinetic (PK) properties of RGLS8429
In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy volunteers to evaluate the safety, tolerability, and PK of RGLS8429.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
solution for subcutaneous injection
solution for subcutaneous injection
ICON Early Phase Services
San Antonio, Texas, United States
Incidence of Adverse Events (AEs)
Incidence and severity of adverse events after administration of RGLS8429
Time frame: Baseline to Day 29
Incidence of DLT and Determination of MTD
Identify dose limiting toxicity and the maximum tolerated dose after RGLS8429 administration
Time frame: Baseline to Day 29
Plasma Half-life (T1/2) of RGLS8429
Measure plasma elimination half-life after RGLS8429 administration
Time frame: Baseline to Day 15
Plasma Clearance of RGLS8429
Measure plasma clearance after RGLS8429 administration
Time frame: Baseline to Day 15
Area Under the Plasma Concentration vs Time Curve (AUC) of RGLS8429
Measure area under the plasma concentration vs time curve after RGLS8429 administration
Time frame: Baseline to Day 15
Amount of RGLS8429 Excreted in Urine
Measure the amount of RGLS8429 excreted in urine after RGLS8429 administration
Time frame: Baseline to 24-hour
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