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

NCT03997734 | Completed Phase 1 DMC

• 1 other identifier: ABS-102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Number of subjects with any adverse events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  From baseline through Day 26

• Number of subjects any serious adverse events (SAEs)

  An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect.

  From baseline through Day 26

Secondary Outcomes (4)

• Safety Assessments on Skin Reaction Evaluation

  From baseline through Day 26

• pharmacokinetic parameters of AB001(Cmax)

  Day 1 and Day 26

• pharmacokinetic parameters of AB001 (AUC)

  Day 1 and Day 26

• bioavailability of AB001

  Day 1 and Day 26

Study Arms (5)

Treatment A-AB001

EXPERIMENTAL

Apply 1 patch of AB001 patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1. Subjects who received the AB001 patch in period 1 will then receive a single oral capsule of active ingredient on Day 20 in period 2.

Drug: AB001; Drug: oral capsule

Treatment B-AB001

EXPERIMENTAL

Apply 2 patches of AB001 patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20.

Drug: AB001

Treatment C

ACTIVE COMPARATOR

Apply 1 patch of positive comparative patch on the lower back of the subjects on either side of the spine without occlusion for 48 hours on Day 1 and then one patch every two days from Days 8 to 20.

Drug: positive comparative patch

Treatment A-Placebo

PLACEBO COMPARATOR

Apply 1 patch of placebo patch on the lower back of the subjects on either side of the spine without occlusion for 12 hours on Day 1 in period 1.

Drug: Placebos

Treatment B-Placebo

PLACEBO COMPARATOR

Apply 2 patches of placebo patches on the lower back of the subjects on side of the spine without occlusion for 12 hours on Day 1 and then once daily from Day 8 to 20.

Drug: Placebos

Interventions

AB001 DRUG

single and repeated dosing

Also known as: topical patch

Treatment A-AB001; Treatment B-AB001

oral capsule DRUG

single dose

Also known as: active ingredient

Treatment A-AB001

positive comparative patch DRUG

single and repeated dosing

Also known as: topical patch

Treatment C

Placebos DRUG

single and repeated dosing

Also known as: topical patch

Treatment A-Placebo; Treatment B-Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects having normal skin without excessive hair growth on tested areas.
• Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial.
• Subjects who are willing to comply with scheduled visits and other trial procedures

You may not qualify if:

• 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
• History of hypersensitivity to NSAIDs
• Clinically significant laboratory abnormalities as judged by the investigator
• Known sensitivity to adhesive tape, component of the test products or topically applied products
• Any active malignancy
• Suffering from severe acne, moderate to severe hirsutism or androgenic alopecia
• Any chronic skin disorder (e.g., eczema, psoriasis) likely to interfere with transdermal drug absorption or assessment of skin tolerability
• 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
• Pregnant and/or nursing women
• Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial
• History of alcohol or drug abuse within 18 months
• Blood donation or significant blood loss within 60 days of dosing or plasma donation within 7 days of dosing
• 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
• 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
• Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

Sponsors & Collaborators

• Frontier Biotechnologies Inc.: lead

Study Sites (1)

The Third People's Hospital of Wuxi

Wuxi, Jiangsu, 214041, China

Location

MeSH Terms

Interventions

Transdermal Patch; Capsules

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Frontier clinical team

  Frontier Biotechnologies Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 25, 2019
• Study Start: June 24, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)