Chronic Low Back Pain
Conditions
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.
Interventions
DRUGAB001
single and repeated dosing
DRUGoral capsule
single dose
DRUGpositive comparative patch
single and repeated dosing
DRUGPlacebos
single and repeated dosing
Sponsors
Frontier Biotechnologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with any adverse events (AEs) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments on Skin Reaction Evaluation | 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) | Day 1 and Day 26 | Peak Plasma Concentration (Cmax) |
| pharmacokinetic parameters of AB001 (AUC) | Day 1 and Day 26 | Area under the plasma concentration versus time curve (AUC) |
| bioavailability of AB001 | Day 1 and Day 26 | To determine the bioavailability of AB001 |
Countries
China
Outcome results
None listed