Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

Launched by BETTA PHARMACEUTICALS CO., LTD. · Oct 8, 2015

Keywords

ClinConnect Summary

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 pa...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For Part 1-Healthy Participants
• • 18-50 years old (inclusive), male or female
• • Male participants should be ≥ 50 kg, female participants should be ≥ 45 kg; Body Mass Index (BMI) should be between 19 and 30 kg/m2 (inclusive)
• • In good health, with no history of diseases of major organs and no BP, HR, ECG or respiratory abnormality on physical examination
• • Adequate hepatic and renal function, as determined by clinical laboratory assessments of blood and urine
• • Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential
• • Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBsAg), hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) at screening; and negative drugs of abuse, alcohol pre dose on Day -1
• • Have signed a written informed consent before entering the study
• • For Part 2 - Patients with Psoriasis
• • Clinical diagnosis of psoriasis for at least six months with multiple affected areas (excluding the face, scalp, genitals and groin) involving 2%-15% of the total Body Surface Area (BSA)
• • 18-65 years old
• • Male participants should be ≥ 50 kg, female participants should be ≥ 45 kg; BMI should be between 19 and 35 kg/m2 (inclusive)
• • In good health, with no history of diseases of major organs and no BP, HR, ECG or respiratory abnormality on physical examination
• • Adequate hepatic and renal function, as determined by clinical laboratory assessments of blood and urine
• • Negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 for females of child bearing potential
• • Negative screen for drugs of abuse, alcohol, HBsAg, HCV and HIV at screening; and negative drugs of abuse, alcohol pre dose on Day1
• • Women of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
• • Have signed a written informed consent before entering the study
• Exclusion Criteria:
• • For Part 1-Healthy Participants
• • Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, respiratory, metabolic conditions (or history), or other pathological or physiological conditions that might interfere with the trial result
• • History of postural hypotension
• • Use of any topical agents (including non-medicated lotions such as sun screen, cosmetics, moisturizing lotion) at the administration site within a week before randomization
• • History of serious skin diseases (as determined by the investigator); no presence of skin ulceration at the test area at the time of the Screening visit
• • Current smoker, or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within two months prior to screening
• • History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last three months
• • For Part 2 - Patients with Psoriasis
• • Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, respiratory, metabolic conditions (or history), or other pathological or physiological conditions that might interfere with the trial result
• • History of postural hypotension
• • Use of any topical agents (including non-medicated lotions such as sun screen, cosmetics, moisturizing lotion) at the administration site within a week before randomization
• • History of serious skin diseases (as determined by the investigator); no presence of skin ulceration at the test area at the time of the Screening visit
• • Excessive smoker(≥10 cigarettes per day), or a history of regular (more than weekly) use of tobacco- or nicotine-containing products within two months prior to screening
• • History of excessive alcohol intake (more than four standard drinks daily, on average) or use of recreational drugs within the last three months