- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02574091
Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Christchurch, New Zealand
- Christchurch Clinical Studies Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Topical administration for twice daily
Other Names:
|
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. |
Topical administration for twice daily.
Other Names:
|
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. |
Topical administration for twice daily.
Other Names:
|
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. |
Topical administration for twice daily.
Other Names:
|
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. |
Topical administration for twice daily
Other Names:
|
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. |
Topical administration for twice daily.
Other Names:
|
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. |
Topical administration for twice daily.
Other Names:
|
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. |
Topical administration for twice daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events in healthy subjects
Time Frame: 8 days
|
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
Time Frame: 14 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance-related skin reactions in healthy adult participants at the tested sites
Time Frame: 8 days
|
Skin irritation and allergy observation (including redness, swelling, itching, pain)
|
8 days
|
Tolerance-related skin reactions in patients with mild to moderate psoriasis at the tested sites
Time Frame: 14 days
|
Skin irritation and allergy observation (including redness, swelling, itching, pain)
|
14 days
|
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
8 days
|
|
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
8 days
|
|
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
AUClast, AUC0-inf will be assessed
|
8 days
|
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
8 days
|
|
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
8 days
|
|
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
8 days
|
|
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
AUC0-12,AUClast, AUC0-inf will be assessed
|
8 days
|
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 8 days
|
8 days
|
|
To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
14 days
|
|
To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
14 days
|
|
To investigate area under the plasma concentration versus time curve(AUC) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
AUClast, AUC0-inf will be assessed
|
14 days
|
To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
14 days
|
|
To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
14 days
|
|
To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
14 days
|
|
To investigate area under the plasma concentration versus time curve(AUC) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis
Time Frame: 14 days
|
AUC0-12,AUClast, AUC0-inf will be assessed
|
14 days
|
To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants
Time Frame: 14 days
|
14 days
|
|
Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis
Time Frame: 14 days
|
14 days
|
|
Dose-toxicity correlation in single-dose and repeat-dose administration
Time Frame: 14 days
|
If observable trends exist between dose applied (in Part 2 of the study) and toxicity and response parameters.
|
14 days
|
Dermatology Life Quality Index (DLQI)
Time Frame: 14 days
|
14 days
|
|
Dose-response correlation in single-dose and repeat-dose administration
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Christopher J Wynne, Christchurch Clinical Studies Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BD-ICC-NZ-I01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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