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

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

AB001

oral capsule

positive comparative patch

Placebos

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.
Subjects having normal skin without excessive hair growth on tested areas.
Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial.
Subjects who are willing to comply with scheduled visits and other trial procedures

Exclusion Criteria:

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
History of hypersensitivity to NSAIDs
Clinically significant laboratory abnormalities as judged by the investigator
Known sensitivity to adhesive tape, component of the test products or topically applied products
Any active malignancy
Suffering from severe acne, moderate to severe hirsutism or androgenic alopecia
Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessment of skin tolerability
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
Pregnant and/or nursing women
Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial
History of alcohol or drug abuse within 18 months
Blood donation or significant blood loss within 60 days of dosing or plasma donation within 7 days of dosing
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
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
Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Sites / Locations

The Third People's Hospital of Wuxi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Treatment A-AB001

Treatment B-AB001

Treatment C

Treatment A-Placebo

Treatment B-Placebo

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of subjects with any adverse events (AEs)

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)

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

Safety Assessments on Skin Reaction Evaluation

Topical Skin Reaction Score(0-2 is a better outcome): 0= no evidence of irritation minimal erythema, barely perceptible definite erythema, readily visible; minimal edema or minimal papular response erythema and papules definite edema erythema, edema and papules vesicular eruption strong reaction spreading beyond application site

pharmacokinetic parameters of AB001(Cmax)

Peak Plasma Concentration (Cmax)

pharmacokinetic parameters of AB001 (AUC)

Area under the plasma concentration versus time curve (AUC)

bioavailability of AB001

To determine the bioavailability of AB001

Full Information

NCT ID

NCT03997734

First Posted

June 19, 2019

Last Updated

March 26, 2020

Sponsor

Frontier Biotechnologies Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03997734

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

June 24, 2019 (Actual)

Primary Completion Date

November 11, 2019 (Actual)

Study Completion Date

November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Frontier Biotechnologies Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A-AB001

Arm Type

Experimental

Arm Description

Arm Title

Treatment B-AB001

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment C

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Treatment A-Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Treatment B-Placebo

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

AB001

Other Intervention Name(s)

topical patch

Intervention Description

single and repeated dosing

Intervention Type

Drug

Intervention Name(s)

oral capsule

Other Intervention Name(s)

active ingredient

Intervention Description

single dose

Intervention Type

Drug

Intervention Name(s)

positive comparative patch

Other Intervention Name(s)

topical patch

Intervention Description

single and repeated dosing

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

topical patch

Intervention Description

single and repeated dosing

Primary Outcome Measure Information:

Title

Number of subjects with any adverse events (AEs)

Description

Time Frame

From baseline through Day 26

Title

Number of subjects any serious adverse events (SAEs)

Description

Time Frame

From baseline through Day 26

Secondary Outcome Measure Information:

Title

Safety Assessments on Skin Reaction Evaluation

Description

Time Frame

From baseline through Day 26

Title

pharmacokinetic parameters of AB001(Cmax)

Description

Peak Plasma Concentration (Cmax)

Time Frame

Day 1 and Day 26

Title

pharmacokinetic parameters of AB001 (AUC)

Description

Area under the plasma concentration versus time curve (AUC)

Time Frame

Day 1 and Day 26

Title

bioavailability of AB001

Description

To determine the bioavailability of AB001

Time Frame

Day 1 and Day 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Subjects having normal skin without excessive hair growth on tested areas. Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial. Subjects who are willing to comply with scheduled visits and other trial procedures Exclusion Criteria: 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 History of hypersensitivity to NSAIDs Clinically significant laboratory abnormalities as judged by the investigator Known sensitivity to adhesive tape, component of the test products or topically applied products Any active malignancy Suffering from severe acne, moderate to severe hirsutism or androgenic alopecia Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessment of skin tolerability 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 Pregnant and/or nursing women Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial History of alcohol or drug abuse within 18 months Blood donation or significant blood loss within 60 days of dosing or plasma donation within 7 days of dosing 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 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 Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frontier clinical team

Organizational Affiliation

Frontier Biotechnologies Inc.

Official's Role

Study Director

Facility Information:

Facility Name

The Third People's Hospital of Wuxi

City

Wuxi

State/Province

Jiangsu

ZIP/Postal Code

214041

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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