Clinical trial NCT03997734: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Low Back Pain
Lead sponsor: Frontier Biotechnologies Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of subjects with any adverse events (AEs)
timeFrame: From baseline through Day 26
measure: Number of subjects any serious adverse events (SAEs)
timeFrame: From baseline through Day 26
Secondary outcomes:
measure: Safety Assessments on Skin Reaction Evaluation
timeFrame: From baseline through Day 26
measure: pharmacokinetic parameters of AB001(Cmax)
timeFrame: Day 1 and Day 26
measure: pharmacokinetic parameters of AB001 (AUC)
timeFrame: Day 1 and Day 26
measure: bioavailability of AB001
timeFrame: Day 1 and Day 26
Other outcomes:
Locations:
city: Wuxi
country: China
facility: The Third People's Hospital of Wuxi
state: Jiangsu
Study officials:
affiliation: Frontier Biotechnologies Inc.
name: Frontier clinical team
role: STUDY_DIRECTOR
References: