Study of X0002 Following Escalating Single and Multiple Doses Administered as Topical Application in Healthy Volunteers

NCT ID: NCT02794740

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-03-29

Brief Summary

Primary Objectives:

To evaluate the safety and tolerability of escalating single and multiple doses of X0002 administered as a topical application.

Secondary Objectives:

To characterize the single and and multiple pharmacokinetics of escalating doses of X0002 and its active metabolite ibuprofen as a topical application.

Conditions

Osteoarthritis

Study Design

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

Study Groups

X0002 First Dose

Preliminary Experiment,4 Subjects,Single-Dose,Once,Non-Blind.

Group Type: EXPERIMENTAL

X0002

Intervention Type: DRUG

External Spray

X0002 Second Dose

8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.

Group Type: EXPERIMENTAL

X0002

Intervention Type: DRUG

External Spray

Placebo Second Dose

2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

External Spray

X0002 Third Dose

8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.

Group Type: EXPERIMENTAL

X0002

Intervention Type: DRUG

External Spray

Placebo Third Dose

2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

External Spray

X0002 Fourth Dose

8 Subjects,Single Dose,Once,Double-Blind.

Group Type: EXPERIMENTAL

X0002

Intervention Type: DRUG

External Spray

Placebo Fourth Dose

2 Subjects,Single Dose,Once,Double-Blind.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

External Spray

Interventions

X0002

External Spray

Intervention Type: DRUG

Placebo

External Spray

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Gender: male or female, each sex ratio does no less 1/3;
• Were between the ages of 18 and 45 years, inclusive. General condition is will;
• Were between the Body Mass Index (BMI) of 19-28, inclusive; BMI=Weight(kg)/Height2 (m2); Weight≥50kg (female) and 60kg (male);
• Nearly half of the year, no child care program and agree to take effective measures to contraception during the study period, blood pregnancy test of women in childbearing age was negative;
• Vital signs (measurement seated after resting 5 minutes) in the following range

1. Temperature (auxiliary temperature): 35.0-37.0℃

2. Systolic Pressure: 90-139mmHg

3. Diastolic Pressure: 60-89mmHg

4. sphygmus: 55-99bpm

• Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials. Were capable of giving informed consents voluntarily, and agreed to comply with the requirements of clinical protocols.

Exclusion Criteria

• Primary disease in important organs;
• Mental or physical disability;
• Familial hereditary diseases;
• Clinically significant history of Electrocardiograph (ECG) abnormality, or Electrocardiograph (ECG) abnormality in the Screening or Baseline;
• Clinically significant abnormities in laboratory examination:

1. Clinically significant abnormities in Liver Function Tests, for example aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) or bilirubin.

2. Creatinine and Urea Nitrogen exceeded the upper limit of normal, or significant abnormities in urinary composition.

3. Clinically significant abnormities of routine blood test, for example anemia, Leukocyte reduced, Platelet significantly reduced,etc.( Combined with adverse events in the laboratory to determine the value of abnormal).

4. Abnormality of immunology, including HIV(human immunodeficiency virus) antibody positive, Hepatitis B surface antigen (HBsAg) positive, HCV(hepatitis C virus) antibody positive or Syphilis antibody positive.

• Drug abusers,or drug screening positive;
• Who was addicted to alcohol and tobacco (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and drinking in the test period;Test positive for nicotine or breath test positive for alcohol(>0.0mg/100ml);
• Took any drug long excretory phase that may affect the study, or in the past 3 months participated in any drug clinical trials;
• Entering the group 4 weeks ago used any prescription drugs ,or used any over the counter (OTC) drugs within 2 weeks (vitamins, herbal tonics, etc.), or before entering the group within 2 weeks took excessively food that effected drug metabolizing enzymes, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in case report form (CRF）;
• A history of gastrointestinal bleeding or peptic ulcers, drugs allergy for aspirin or hypersensitivity to aspirin or other NSAIDs (Non-Steroidal Antiinflammatory Drugs), or a history of asthma or other allergic-type reactions after taking aspirin or other NSAIDs(Non-Steroidal Antiinflammatory Drugs); A history of intolerance or hypersensitivity to ibuprofenamine hydrochloride or any excipients or to the diluent ethanol;
• Donation or blood collection, or acute loss of blood during the 3 months prior to screening( more than 400ml);
• Had skin diseases wound or other symptom, investigators consider that maybe unsafe for subjects or effect of evaluation for application sites;
• There was a clinical significance history of allergy for drugs or food, or atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug allergy for test drugs or similar drugs;
• Lactating women, pregnant women or unable to take effective contraceptive measures;
• Researchers believed that participants not suitable to take the test for other factors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin XinChen-Techfields Pharma Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Xinchen-Techfields Pharma Co. Ltd

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

TFR-X0002-101

Identifier Type: -

Identifier Source: org_study_id