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

CompletedPhase 1NCT03997734
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Interventions
  • Drug: AB001
  • Drug: oral capsule
  • Drug: positive comparative patch
  • Drug: Placebos
Sponsor
Frontier Biotechnologies Inc.
Start date
2019-06-24
Primary completion
2019-11-11
Sex
All
Age range
from 18 Years to 45 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
China
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03997734