Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-01 @ 5:07 AM
Study NCT ID:
NCT03997734
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects
Sponsor:
Frontier Biotechnologies Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: