NCT03997734

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	AB001	single and repeated dosing
DRUG	oral capsule	single dose
DRUG	positive comparative patch	single and repeated dosing
DRUG	Placebos	single and repeated dosing

Timeline

• Start date: 2019-06-24
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2019-06-25
• Last updated: 2020-03-30

Locations

1 site across 1 country: China