This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis.
Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for the treatment of advanced non-small-cell lung cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a single-center, randomized, double-blind, placebo-controlled study of icotinib hydrochloride cream by topical administration. The study is designed in two parts in healthy subjects (part 1) followed by patients with mild to moderate psoriasis (part 2). 1% and 2% icotinib hydrochloride cream will be initially applied to healthy subjects. Once the study in healthy adults shows favorable safety and tolerability, a study in patients with mild to moderate psoriasis will be followed. Approximately 28 subjects will be enrolled, including 12 healthy subjects (Part 1) and 16 patients with psoriasis (Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Topical administration for twice daily
Topical administration for twice daily.
Topical administration for twice daily.
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Adverse events in healthy subjects
Incidence and severity of Adverse Events (AE) Vital signs (temperature, Heart Rate (HR), BP and respiration); Clinical laboratory assessments (serum chemistry, hematology and urinalysis); ECG; Use of concomitant medications
Time frame: 8 days
Adverse events in patients with mild to moderate psoriasis
Incidence and severity of AEs; Vital signs (temperature, HR, BP and respiration); Clinical laboratory assessments (serum chemistry, hematology and urinalysis); ECG; Use of concomitant medications
Time frame: 14 days
Tolerance-related skin reactions in healthy adult participants at the tested sites
Skin irritation and allergy observation (including redness, swelling, itching, pain)
Time frame: 8 days
Tolerance-related skin reactions in patients with mild to moderate psoriasis at the tested sites
Skin irritation and allergy observation (including redness, swelling, itching, pain)
Time frame: 14 days
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
AUClast, AUC0-inf will be assessed
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Time frame: 8 days
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
AUC0-12,AUClast, AUC0-inf will be assessed
Time frame: 8 days
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 8 days
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
AUClast, AUC0-inf will be assessed
Time frame: 14 days
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time frame: 14 days
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
AUC0-12,AUClast, AUC0-inf will be assessed
Time frame: 14 days
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time frame: 14 days
Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis
Time frame: 14 days
Dose-toxicity correlation in single-dose and repeat-dose administration
If observable trends exist between dose applied (in Part 2 of the study) and toxicity and response parameters.
Time frame: 14 days
Dermatology Life Quality Index (DLQI)
Time frame: 14 days
Dose-response correlation in single-dose and repeat-dose administration
Time frame: 14 days