Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

NCT02574091 | Completed Phase 1

• 1 other identifier: BD-ICC-NZ-I01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

EGFR inhibitor; topical agent; psoriasis; phase 1

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 days

Secondary Outcomes (22)

• Tolerance-related skin reactions in healthy adult participants at the tested sites

  8 days

• Tolerance-related skin reactions in patients with mild to moderate psoriasis at the tested sites

  14 days

• To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants

  8 days

• To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants

  8 days

• To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in healthy adult participants

  8 days

Study Arms (8)

Cohort 1-Experimental

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.

Drug: 1% icotinib hydrochloride cream

Cohort 1-Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Cohort 2-Experimental

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.

Drug: 2% icotinib hydrochloride cream

Cohort 2-Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Cohort 3-Experimental

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.

Drug: 1% icotinib hydrochloride cream

Cohort 3-Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Cohort 4-Experimental

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.

Drug: 2% icotinib hydrochloride cream

Cohort 4-Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

1% icotinib hydrochloride cream DRUG

Topical administration for twice daily

Also known as: no other name

Cohort 1-Experimental; Cohort 3-Experimental

2% icotinib hydrochloride cream DRUG

Topical administration for twice daily.

Also known as: no other name

Cohort 2-Experimental; Cohort 4-Experimental

Placebo DRUG

Topical administration for twice daily.

Also known as: Blank Cream

Cohort 1-Placebo; Cohort 2-Placebo; Cohort 3-Placebo; Cohort 4-Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Part 1-Healthy Participants
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Christchurch Clinical Studies Trust

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christopher J Wynne

  Christchurch Clinical Studies Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 12, 2015
• Study Start: November 26, 2015
• Primary Completion: February 19, 2017
• Study Completion: February 19, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

NZ (1)