Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574091
• Other study ID #: BD-ICC-NZ-I01
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2015
• Last updated: July 12, 2017
• Start date: November 26, 2015
• Est. completion date: February 19, 2017

Study information

• Verified date: July 2017
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 19, 2017
• Est. primary completion date: February 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 1% icotinib hydrochloride cream
Topical administration for twice daily
• 2% icotinib hydrochloride cream
Topical administration for twice daily.
• Placebo
Topical administration for twice daily.

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust	Christchurch

Sponsors (2)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.	Quintiles, Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tolerance-related skin reactions in healthy adult participants at the tested sites	Skin irritation and allergy observation (including redness, swelling, itching, pain)	8 days
Secondary	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)	14 days
Secondary	To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants		8 days
Secondary	To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in healthy adult participants		8 days
Secondary	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	8 days
Secondary	To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in healthy adult participants		8 days
Secondary	To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants		8 days
Secondary	To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants		8 days
Secondary	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	8 days
Secondary	To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants		8 days
Secondary	To investigate peak plasma concentration (Cmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		14 days
Secondary	To investigate time maximum concentration observed(tmax) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		14 days
Secondary	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	14 days
Secondary	To investigate half life(t1/2) of single-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		14 days
Secondary	To investigate stable peak plasma concentration (Cmaxss) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		14 days
Secondary	To investigate time maximum concentration observed(tmax) of repeat-dose Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis		14 days
Secondary	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	14 days
Secondary	To investigate half life(t1/2) of repeat-dose Icotinib Hydrochloride Cream in healthy adult participants		14 days
Secondary	Psoriasis Area and Severity Index (PASI) Scores in patients with mild to moderate psoriasis		14 days
Secondary	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.	14 days
Secondary	Dermatology Life Quality Index (DLQI)		14 days
Secondary	Dose-response correlation in single-dose and repeat-dose administration		14 days