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

• Status: Completed
• Trial end date: 2019-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Frontier Biotechnologies Inc.

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.