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出境医 / 临床实验 / Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects

Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects

Study Description
Brief Summary:
The study evaluates the safety, tolerability and pharmacokinetics of single and repeated doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical positive comparative patch.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: AB001 Drug: oral capsule Drug: positive comparative patch Drug: Placebos Phase 1

Detailed Description:

Eligible subjects will be randomly assigned to Treatment goup A, B and C.

In the experiment group A, 12 subjects with a ratio of 10:2 will receive one patch of AB001 or placebo batch on Day 1 of period 1, respectively, after a wash-out period of 14 days, 10 subjects received AB001 patch will be administered with an oral capsule of active ingredient on Day 20 of period 2.

In the experiment group B, 12 subjects with a ratio of 10:2 will receive two patches of AB001 or two placebo batches on Day 1 respectively, and then two patches daily from Day 8 to Day 20.

In the active comparator group C, 10 subjects will receive one patch of positive comparative patch on Day 1, and then once patch every two days from Day 8 to Day 20.

The tolerability, safety and pharmacokinetics of topical AB001 patch will be assessed in this study.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Tolerability, Safety and Pharmacokinetics of a Topical Patch AB001 Following Single and Repeated Administration in Healthy Subjects
Actual Study Start Date : June 24, 2019
Actual Primary Completion Date : November 11, 2019
Actual Study Completion Date : November 11, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment A-AB001
Apply 1 patch of AB001 patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1. Subjects who received the AB001 patch in period 1 will then receive a single oral capsule of active ingredient on Day 20 in period 2.
Drug: AB001
single and repeated dosing
Other Name: topical patch

Drug: oral capsule
single dose
Other Name: active ingredient

Experimental: Treatment B-AB001
Apply 2 patches of AB001 patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20.
Drug: AB001
single and repeated dosing
Other Name: topical patch

Active Comparator: Treatment C
Apply 1 patch of positive comparative patch on the lower back of the subjects on either side of the spine without occlusion for 48 hours on Day 1 and then one patch every two days from Days 8 to 20.
Drug: positive comparative patch
single and repeated dosing
Other Name: topical patch

Placebo Comparator: Treatment A-Placebo
Apply 1 patch of placebo patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1.
Drug: Placebos
single and repeated dosing
Other Name: topical patch

Placebo Comparator: Treatment B-Placebo
Apply 2 patches of placebo patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20.
Drug: Placebos
single and repeated dosing
Other Name: topical patch

Outcome Measures
Primary Outcome Measures :
  1. Number of subjects with any adverse events (AEs) [ Time Frame: From baseline through Day 26 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  2. Number of subjects any serious adverse events (SAEs) [ Time Frame: From baseline through Day 26 ]
    An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect.


Secondary Outcome Measures :
  1. Safety Assessments on Skin Reaction Evaluation [ Time Frame: From baseline through Day 26 ]

    Topical Skin Reaction Score(0-2 is a better outcome):

    0= no evidence of irritation

    1. minimal erythema, barely perceptible
    2. definite erythema, readily visible; minimal edema or minimal papular response
    3. erythema and papules
    4. definite edema
    5. erythema, edema and papules
    6. vesicular eruption
    7. strong reaction spreading beyond application site

  2. pharmacokinetic parameters of AB001(Cmax) [ Time Frame: Day 1 and Day 26 ]
    Peak Plasma Concentration (Cmax)

  3. pharmacokinetic parameters of AB001 (AUC) [ Time Frame: Day 1 and Day 26 ]
    Area under the plasma concentration versus time curve (AUC)

  4. bioavailability of AB001 [ Time Frame: Day 1 and Day 26 ]
    To determine the bioavailability of AB001


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female subjects between 18 and 45 years with a BMI of 18 to 30 kg/m2, inclusive, and weigh at least 45 kg.
  2. Subjects having normal skin without excessive hair growth on tested areas.
  3. Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial.
  4. Subjects who are willing to comply with scheduled visits and other trial procedures

Exclusion Criteria:

  1. A history or presence of significant cardiovascular, neurological, hematological, psychiatric, infectious, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other conditions known to interfere with the topical absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator
  2. History of hypersensitivity to NSAIDs
  3. Clinically significant laboratory abnormalities as judged by the investigator
  4. Known sensitivity to adhesive tape, component of the test products or topically applied products
  5. Any active malignancy
  6. Suffering from severe acne, moderate to severe hirsutism or androgenic alopecia
  7. Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessment of skin tolerability
  8. Skin abnormalities likely to be aggravated by the study medication, such as dermatological diseases or infections, rash, skin sensitive to topical preparations or adhesive dressings
  9. Pregnant and/or nursing women
  10. Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial
  11. History of alcohol or drug abuse within 18 months
  12. Blood donation or significant blood loss within 60 days of dosing or plasma donation within 7 days of dosing
  13. Use of any medication within 4 weeks prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects
  14. Subjects who cannot avoid, throughout the duration of the trial, any swimming, any washing of the back, and sauna or any intense physical activity that might result in excessive sweating
  15. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Contacts and Locations

Locations
Layout table for location information
China, Jiangsu
The Third People's Hospital of Wuxi
Wuxi, Jiangsu, China, 214041
Sponsors and Collaborators
Frontier Biotechnologies Inc.
Investigators
Layout table for investigator information
Study Director: Frontier clinical team Frontier Biotechnologies Inc.
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date March 30, 2020
Actual Study Start Date  ICMJE June 24, 2019
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Number of subjects with any adverse events (AEs) [ Time Frame: From baseline through Day 26 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Number of subjects any serious adverse events (SAEs) [ Time Frame: From baseline through Day 26 ]
    An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
Safety Assessments on AEs [ Time Frame: From baseline through Day 26 ]
numbers of percentage
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Safety Assessments on Skin Reaction Evaluation [ Time Frame: From baseline through Day 26 ]
    Topical Skin Reaction Score(0-2 is a better outcome): 0= no evidence of irritation
    1. minimal erythema, barely perceptible
    2. definite erythema, readily visible; minimal edema or minimal papular response
    3. erythema and papules
    4. definite edema
    5. erythema, edema and papules
    6. vesicular eruption
    7. strong reaction spreading beyond application site
  • pharmacokinetic parameters of AB001(Cmax) [ Time Frame: Day 1 and Day 26 ]
    Peak Plasma Concentration (Cmax)
  • pharmacokinetic parameters of AB001 (AUC) [ Time Frame: Day 1 and Day 26 ]
    Area under the plasma concentration versus time curve (AUC)
  • bioavailability of AB001 [ Time Frame: Day 1 and Day 26 ]
    To determine the bioavailability of AB001
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
  • Safety Assessments on Skin Reaction Evaluation [ Time Frame: From baseline through Day 26 ]
    Topical Skin Reaction Score
  • pharmacokinetic parameters of AB001(Cmax) [ Time Frame: Day 1 and Day 26 ]
    Peak Plasma Concentration (Cmax)
  • pharmacokinetic parameters of AB001 (AUC) [ Time Frame: Day 1 and Day 26 ]
    Area under the plasma concentration versus time curve (AUC)
  • bioavailability of AB001 [ Time Frame: Day 1 and Day 26 ]
    To determine the bioavailability of AB001
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects
Official Title  ICMJE A Phase 1, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Tolerability, Safety and Pharmacokinetics of a Topical Patch AB001 Following Single and Repeated Administration in Healthy Subjects
Brief Summary The study evaluates the safety, tolerability and pharmacokinetics of single and repeated doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical positive comparative patch.
Detailed Description

Eligible subjects will be randomly assigned to Treatment goup A, B and C.

In the experiment group A, 12 subjects with a ratio of 10:2 will receive one patch of AB001 or placebo batch on Day 1 of period 1, respectively, after a wash-out period of 14 days, 10 subjects received AB001 patch will be administered with an oral capsule of active ingredient on Day 20 of period 2.

In the experiment group B, 12 subjects with a ratio of 10:2 will receive two patches of AB001 or two placebo batches on Day 1 respectively, and then two patches daily from Day 8 to Day 20.

In the active comparator group C, 10 subjects will receive one patch of positive comparative patch on Day 1, and then once patch every two days from Day 8 to Day 20.

The tolerability, safety and pharmacokinetics of topical AB001 patch will be assessed in this study.

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 Chronic Low Back Pain
Intervention  ICMJE
  • Drug: AB001
    single and repeated dosing
    Other Name: topical patch
  • Drug: oral capsule
    single dose
    Other Name: active ingredient
  • Drug: positive comparative patch
    single and repeated dosing
    Other Name: topical patch
  • Drug: Placebos
    single and repeated dosing
    Other Name: topical patch
Study Arms  ICMJE
  • Experimental: Treatment A-AB001
    Apply 1 patch of AB001 patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1. Subjects who received the AB001 patch in period 1 will then receive a single oral capsule of active ingredient on Day 20 in period 2.
    Interventions:
    • Drug: AB001
    • Drug: oral capsule
  • Experimental: Treatment B-AB001
    Apply 2 patches of AB001 patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20.
    Intervention: Drug: AB001
  • Active Comparator: Treatment C
    Apply 1 patch of positive comparative patch on the lower back of the subjects on either side of the spine without occlusion for 48 hours on Day 1 and then one patch every two days from Days 8 to 20.
    Intervention: Drug: positive comparative patch
  • Placebo Comparator: Treatment A-Placebo
    Apply 1 patch of placebo patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1.
    Intervention: Drug: Placebos
  • Placebo Comparator: Treatment B-Placebo
    Apply 2 patches of placebo patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20.
    Intervention: Drug: Placebos
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 23, 2019)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 11, 2019
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male and female subjects between 18 and 45 years with a BMI of 18 to 30 kg/m2, inclusive, and weigh at least 45 kg.
  2. Subjects having normal skin without excessive hair growth on tested areas.
  3. Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial.
  4. Subjects who are willing to comply with scheduled visits and other trial procedures

Exclusion Criteria:

  1. A history or presence of significant cardiovascular, neurological, hematological, psychiatric, infectious, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other conditions known to interfere with the topical absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator
  2. History of hypersensitivity to NSAIDs
  3. Clinically significant laboratory abnormalities as judged by the investigator
  4. Known sensitivity to adhesive tape, component of the test products or topically applied products
  5. Any active malignancy
  6. Suffering from severe acne, moderate to severe hirsutism or androgenic alopecia
  7. Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessment of skin tolerability
  8. Skin abnormalities likely to be aggravated by the study medication, such as dermatological diseases or infections, rash, skin sensitive to topical preparations or adhesive dressings
  9. Pregnant and/or nursing women
  10. Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial
  11. History of alcohol or drug abuse within 18 months
  12. Blood donation or significant blood loss within 60 days of dosing or plasma donation within 7 days of dosing
  13. Use of any medication within 4 weeks prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects
  14. Subjects who cannot avoid, throughout the duration of the trial, any swimming, any washing of the back, and sauna or any intense physical activity that might result in excessive sweating
  15. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
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 NCT03997734
Other Study ID Numbers  ICMJE ABS-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frontier Biotechnologies Inc.
Study Sponsor  ICMJE Frontier Biotechnologies Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Frontier clinical team Frontier Biotechnologies Inc.
PRS Account Frontier Biotechnologies Inc.
Verification Date March 2020

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

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