Condition or disease | Intervention/treatment | Phase |
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Chronic Low Back Pain | Drug: AB001 Drug: oral capsule Drug: positive comparative patch Drug: Placebos | Phase 1 |
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 : | 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 |
Arm | Intervention/treatment |
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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.
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Drug: AB001
single and repeated dosing
Other Name: topical patch
Drug: oral capsule single dose
Other Name: active ingredient
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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.
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Drug: AB001
single and repeated dosing
Other Name: topical patch
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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.
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Drug: positive comparative patch
single and repeated dosing
Other Name: topical patch
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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.
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Drug: Placebos
single and repeated dosing
Other Name: topical patch
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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.
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Drug: Placebos
single and repeated dosing
Other Name: topical patch
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Topical Skin Reaction Score(0-2 is a better outcome):
0= no evidence of irritation
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
China, Jiangsu | |
The Third People's Hospital of Wuxi | |
Wuxi, Jiangsu, China, 214041 |
Study Director: | Frontier clinical team | Frontier Biotechnologies Inc. |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE |
Safety Assessments on AEs [ Time Frame: From baseline through Day 26 ] numbers of percentage
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Chronic Low Back Pain | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Frontier Biotechnologies Inc. | ||||
Study Sponsor ICMJE | Frontier Biotechnologies Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |