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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794740
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tianjin XinChen-Techfields Pharma Co., LTD.

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: X0002 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: X0002 First Dose
Preliminary Experiment,4 Subjects,Single-Dose,Once,Non-Blind.
Drug: X0002
External Spray

Experimental: X0002 Second Dose
8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
Drug: X0002
External Spray

Placebo Comparator: Placebo Second Dose
2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
Drug: Placebo
External Spray

Experimental: X0002 Third Dose
8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
Drug: X0002
External Spray

Placebo Comparator: Placebo Third Dose
2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
Drug: Placebo
External Spray

Experimental: X0002 Fourth Dose
8 Subjects,Single Dose,Once,Double-Blind.
Drug: X0002
External Spray

Placebo Comparator: Placebo Fourth Dose
2 Subjects,Single Dose,Once,Double-Blind.
Drug: Placebo
External Spray




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Single Dose Arms:6days;Multiple Doses Arms:17days ]
    Adverse Event; Vital Signs; Physical Examination; Laboratory Examination; Electrocardiograph; Skin Irritation


Secondary Outcome Measures :
  1. Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax]) [ Time Frame: Single Dose Arms:0-120hours;Multiple Doses Arms:0-120hours post-dose;11th day pre-dose;12th day 0-120 hours post-dose. ]

Other Outcome Measures:
  1. Pharmacokinetic parameters(Area Under Curve [AUC]) [ Time Frame: Single Dose Arms:0-120hours;Multiple Doses Arms:0-120hours post-dose;11th day pre-dose;12th day 0-120 hours post-dose. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794740


Locations
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China, Tianjin
Tianjin Xinchen-Techfields Pharma Co. Ltd
Tianjin, Tianjin, China, 300000
Sponsors and Collaborators
Tianjin XinChen-Techfields Pharma Co., LTD.
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Responsible Party: Tianjin XinChen-Techfields Pharma Co., LTD.
ClinicalTrials.gov Identifier: NCT02794740    
Other Study ID Numbers: TFR-X0002-101
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Keywords provided by Tianjin XinChen-Techfields Pharma Co., LTD.:
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases