Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

NCT ID: NCT02574091

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-26
• Study Completion Date: 2017-02-19

Brief 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.

Detailed Description

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).

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1-Experimental

4 healthy adult participants will be randomized to receive 1% icotinib hydrochloride cream, applied twice daily for 7 consecutive days (final dose on the morning of Day 8).

The drug will be used topically to the back of each participant within an area of 15cm x 25cm.

Group Type: EXPERIMENTAL

1% icotinib hydrochloride cream

Intervention Type: DRUG

Topical administration for twice daily

Cohort 1-Placebo

2 healthy adult participants will be randomized to receive placebo (blank cream), applied twice daily for 7 consecutive days (final dose on the morning of Day 8).

The drug will be used topically to the back of each participant within an area of 15cm x 25cm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical administration for twice daily.

Cohort 2-Experimental

4 healthy adult participants will be randomized to receive 2% icotinib hydrochloride cream, applied twice daily for 7 consecutive days (final dose on the morning of Day 8).

The drug will be used topically to the back of each participant within an area of 15cm x 25cm.

Group Type: EXPERIMENTAL

2% icotinib hydrochloride cream

Intervention Type: DRUG

Topical administration for twice daily.

Cohort 2-Placebo

2 healthy adult participants will be randomized to receive matching placebo, applied twice daily for 7 consecutive days (final dose on the morning of Day 8).

The drug will be used topically to the back of each participant within an area of 15cm x 25cm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical administration for twice daily.

Cohort 3-Experimental

6 patients with mild to moderate psoriasis will be randomized to receive 1% icotinib hydrochloride cream, applied twice daily for 13 consecutive days (final dose on the morning of Day 14).

The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only.

Group Type: EXPERIMENTAL

1% icotinib hydrochloride cream

Intervention Type: DRUG

Topical administration for twice daily

Cohort 3-Placebo

2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 13 consecutive days (final dose on the morning of Day 14).

The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical administration for twice daily.

Cohort 4-Experimental

6 patients with mild to moderate psoriasis will be randomized to receive 2% icotinib hydrochloride cream, applied twice daily for 13 consecutive days (final dose on the morning of Day 14).

The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only.

Group Type: EXPERIMENTAL

2% icotinib hydrochloride cream

Intervention Type: DRUG

Topical administration for twice daily.

Cohort 4-Placebo

2 patients with mild to moderate psoriasis will be randomized to receive matching placebo, applied twice daily for 13 consecutive days (final dose on the morning of Day 14).

The drug will be applied topically to the psoriasis site (excluding face, scalp, genital and groin) on the arms and/or legs and/or trunk only.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical administration for twice daily.

Interventions

1% icotinib hydrochloride cream

Topical administration for twice daily

Intervention Type: DRUG

2% icotinib hydrochloride cream

Topical administration for twice daily.

Intervention Type: DRUG

Placebo

Topical administration for twice daily.

Intervention Type: DRUG

Other Intervention Names

no other name; no other name; Blank Cream

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Wynne

Role: STUDY_CHAIR

Christchurch Clinical Studies Trust

Locations

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Countries

New Zealand

Other Identifiers

BD-ICC-NZ-I01

Identifier Type: -

Identifier Source: org_study_id