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

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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.

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date September 12, 2018
Study Start Date  ICMJE June 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2016)
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. ]
Single Dose Arms:0 (pre-dose),and 0.5,1,2,4,6,8,10,12,16,24,32,36,40,48,72,96,120hours post-dose;Multiple:First Day 0(pre-dose),0.5,1,2,4,6,8,10,12,16,24,32,36,40,48,72,96,120h post-dose;11th day pre-dose;12th day 0(pre-dose),0.5,1,2,4,6,8,10,12,16,24,32,36,40,48,72,96, 120 hours post-dose.
Current Other Pre-specified Outcome Measures
 (submitted: September 14, 2016)
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. ]
Original Other Pre-specified Outcome Measures
 (submitted: June 3, 2016)
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. ]
Single Dose Arms:0 (pre-dose),and 0.5,1,2,4,6,8,10,12,16,24,32,36,40,48,72,96,120hours post-dose;Multiple:First Day 0(pre-dose),0.5,1,2,4,6,8,10,12,16,24,32,36,40,48,72,96,120h post-dose;11th day pre-dose;12th day 0(pre-dose),0.5,1,2,4,6,8,10,12,16,24,32,36,40,48,72,96, 120 hours post-dose.
 
Descriptive Information
Brief Title  ICMJE Study of X0002 Following Escalating Single and Multiple Doses Administered as Topical Application in Healthy Volunteers
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: X0002
    External Spray
  • Drug: Placebo
    External Spray
Study Arms  ICMJE
  • Experimental: X0002 First Dose
    Preliminary Experiment,4 Subjects,Single-Dose,Once,Non-Blind.
    Intervention: Drug: X0002
  • Experimental: X0002 Second Dose
    8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
    Intervention: Drug: X0002
  • Placebo Comparator: Placebo Second Dose
    2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
    Intervention: Drug: Placebo
  • Experimental: X0002 Third Dose
    8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
    Intervention: Drug: X0002
  • Placebo Comparator: Placebo Third Dose
    2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind.
    Intervention: Drug: Placebo
  • Experimental: X0002 Fourth Dose
    8 Subjects,Single Dose,Once,Double-Blind.
    Intervention: Drug: X0002
  • Placebo Comparator: Placebo Fourth Dose
    2 Subjects,Single Dose,Once,Double-Blind.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 29, 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794740
Other Study ID Numbers  ICMJE TFR-X0002-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tianjin XinChen-Techfields Pharma Co., LTD.
Study Sponsor  ICMJE Tianjin XinChen-Techfields Pharma Co., LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tianjin XinChen-Techfields Pharma Co., LTD.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP