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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02574091




Registration number
NCT02574091
Ethics application status
Date submitted
28/09/2015
Date registered
12/10/2015
Date last updated
13/07/2017

Titles & IDs
Public title
Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients
Scientific title
A Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Icotinib Hydrochloride Cream in Healthy Adult Participants, Followed by Patients With Mild to Moderate Psoriasis
Secondary ID [1] 0 0
BD-ICC-NZ-I01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 1% icotinib hydrochloride cream
Treatment: Drugs - 2% icotinib hydrochloride cream
Treatment: Drugs - Placebo

Experimental: 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.

Placebo Comparator: 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.

Experimental: 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.

Placebo Comparator: 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.

Experimental: 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.

Placebo Comparator: 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.

Experimental: 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.

Placebo Comparator: 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.


Treatment: Drugs: 1% icotinib hydrochloride cream
Topical administration for twice daily

Treatment: Drugs: 2% icotinib hydrochloride cream
Topical administration for twice daily.

Treatment: Drugs: Placebo
Topical administration for twice daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
8 days
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
14 days
Secondary outcome [1] 0 0
Tolerance-related skin reactions in healthy adult participants at the tested sites - Skin irritation and allergy observation (including redness, swelling, itching, pain)
Timepoint [1] 0 0
8 days
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [3] 0 0
8 days
Secondary outcome [4] 0 0
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [4] 0 0
8 days
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
8 days
Secondary outcome [6] 0 0
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [6] 0 0
8 days
Secondary outcome [7] 0 0
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [7] 0 0
8 days
Secondary outcome [8] 0 0
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [8] 0 0
8 days
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
8 days
Secondary outcome [10] 0 0
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [10] 0 0
8 days
Secondary outcome [11] 0 0
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Timepoint [11] 0 0
14 days
Secondary outcome [12] 0 0
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Timepoint [12] 0 0
14 days
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
14 days
Secondary outcome [14] 0 0
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Timepoint [14] 0 0
14 days
Secondary outcome [15] 0 0
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Timepoint [15] 0 0
14 days
Secondary outcome [16] 0 0
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Timepoint [16] 0 0
14 days
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
14 days
Secondary outcome [18] 0 0
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Timepoint [18] 0 0
14 days
Secondary outcome [19] 0 0
Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis
Timepoint [19] 0 0
14 days
Secondary outcome [20] 0 0
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.
Timepoint [20] 0 0
14 days
Secondary outcome [21] 0 0
Dermatology Life Quality Index (DLQI)
Timepoint [21] 0 0
14 days
Secondary outcome [22] 0 0
Dose-response correlation in single-dose and repeat-dose administration
Timepoint [22] 0 0
14 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Betta Pharmaceuticals Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02574091
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher J Wynne
Address 0 0
Christchurch Clinical Studies Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications