Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

• Status: Completed
• Trial end date: 2017-02-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Collaborator: Quintiles, Inc.

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