OsteoarthritisPhase 1NCT02794740
Study of X0002 Following Escalating Single and Multiple Doses Administered as Topical Application in Healthy Volunteers
A Phase 1 study testing X0002 in people with Osteoarthritis, run by Tianjin XinChen-Techfields Pharma Co., LTD. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- X0002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to 29 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Temperature (auxiliary temperature): 35.0-37.0℃
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- Systolic Pressure: 90-139mmHg
- Diastolic Pressure: 60-89mmHg
- 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.
Who cannot join
- 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:
- Clinically significant abnormities in Liver Function Tests, for example aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) or bilirubin.
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- Creatinine and Urea Nitrogen exceeded the upper limit of normal, or significant abnormities in urinary composition.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Xinchen-Techfields Pharma Co. Ltd
Tianjin, Tianjin Municipality, 300000
About this study
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
- Being tested
- X0002, Placebo
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X0002Drug
External Spray
PlaceboDrug
External Spray
| Study group | Role | What they receive |
|---|---|---|
| X0002 First Dose | Experimental | Preliminary Experiment,4 Subjects,Single-Dose,Once,Non-Blind. Receives: Drug: X0002 |
| X0002 Second Dose | Experimental | 8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. Receives: Drug: X0002 |
| Placebo Second Dose | Placebo comparator | 2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. Receives: Drug: Placebo |
| X0002 Third Dose | Experimental | 8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. Receives: Drug: X0002 |
| Placebo Third Dose | Placebo comparator | 2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. Receives: Drug: Placebo |
| X0002 Fourth Dose | Experimental | 8 Subjects,Single Dose,Once,Double-Blind. Receives: Drug: X0002 |
| Placebo Fourth Dose | Placebo comparator | 2 Subjects,Single Dose,Once,Double-Blind. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Adverse Event; Vital Signs; Physical Examination; Laboratory Examination; Electrocardiograph; Skin Irritation
Measured: Single Dose Arms:6days;Multiple Doses Arms:17days
Secondary outcomes (1)
Pharmacokinetic parameters(Maximum Plasma Concentration [Cmax])
Measured: Single Dose Arms:0-120hours;Multiple Doses Arms:0-120hours post-dose;11th day pre-dose;12th day 0-120 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin XinChen-Techfields Pharma Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794740
- Sponsor's protocol ID
- TFR-X0002-101
- Status last verified
- Sep 2018
- First submitted
- 1 Jun 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of X0002 Following Escalating Single and Multiple Doses Administered as Topical Application in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02794740
- Acronym / sponsor ID
- TFR-X0002-101
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tianjin XinChen-Techfields Pharma Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| X0002 First Dose | Experimental | Drug: X0002Preliminary Experiment,4 Subjects,Single-Dose,Once,Non-Blind. |
| X0002 Second Dose | Experimental | Drug: X00028 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| Placebo Second Dose | Placebo comparator | Drug: Placebo2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| X0002 Third Dose | Experimental | Drug: X00028 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| Placebo Third Dose | Placebo comparator | Drug: Placebo2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| X0002 Fourth Dose | Experimental | Drug: X00028 Subjects,Single Dose,Once,Double-Blind. |
| Placebo Fourth Dose | Placebo comparator | Drug: Placebo2 Subjects,Single Dose,Once,Double-Blind. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X0002External Spray | Drug | X0002 First Dose, X0002 Fourth Dose, X0002 Second Dose, X0002 Third Dose |
| PlaceboExternal Spray | Drug | Placebo Fourth Dose, Placebo Second Dose, Placebo Third Dose |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing X0002 in people with Osteoarthritis, run by Tianjin XinChen-Techfields Pharma Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Single Dose Arms:6days;Multiple Doses Arms:17days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.