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

NCT03997734 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-03-30

No results posted yet for this study

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.

Conditions

  • Chronic Low Back Pain

Interventions

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

Sponsors & Collaborators

  • Frontier Biotechnologies Inc.

    lead INDUSTRY

Principal Investigators

  • Frontier clinical team · Frontier Biotechnologies Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2019-11-11
Completion
2019-11-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997734 on ClinicalTrials.gov