This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
40
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
Syneos Health
Miami, Florida, United States
The number of subjects with treatment related adverse events as assessed
Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs
Time frame: Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6)
Time to observed Cmax (Tmax)for D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax
Time frame: Timeframe: Day 1-Day7
Area under the plasma concentration-time curve (AUC) for D-0120
Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC
Time frame: Day 1-Day 7
Maximum Observed Plasma Concentration (Cmax) of D-0120
Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax
Time frame: Day 1-Day 7
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