This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.
This is a single center, randomized, double-blind, dose escalation, placebo-controlled, first-in-humans phase 1 study to investigate the safety and tolerability of single and multiple escalating doses of ICP-022 in healthy volunteers. 40 healthy male participants (aged between 18 and 55 years of age inclusive) will be enrolled into Part 1 (single escalating dose administration) of this study, and additional 24 male subjects will be enrolled in Part 2 (multiple escalating dose administration). Part 1a consists of 5 cohorts of 8 participants each, while Part 2 includes 3 cohorts of 8 participants each. Part 1a consists a treatment period with single oral dosing, and a safety follow-up to 7 days after dosing. Cohort 4 of Part 1a will return on Day 8 to repeat the study under fed condition in Part 1b. Part 2 consists a treatment period with multiple dosing (once per day for 14 consecutive days), and a safety follow-up until 28 days after dosing. All subjects will receive either ICP-022 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
CMAX Clinical Research
Adelaide, South Australia, Australia
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events will be collected and the percentage of AE of different grades will be assessed.
Time frame: up to 28 days
Maximum plasma drug concentrations (Cmax)
Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 16 days
Time of maximum plasma drug concentrations (Tmax)
Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded.
Time frame: up to 16 days
Area under the concentration time curve up to the time "t" (AUC(0-t))
Area under the concentration time curve up to the time "t" (AUC(0-t)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 16 days
Area under the concentration time curve up to the last data point above LOQ (AUC(last))
Area under the concentration time curve up to the last data point above LOQ (AUC(last)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 16 days
Apparent half-life for designated elimination phases (t½)
Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 16 days
Percent target occupancy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PBMC from individual subject before and after dosing will be collected and the target occupancy will be determined by ELISA. The percent of target occupancy will be compared descritively.
Time frame: up to 16 days