Chronic Low Back PainPhase 1NCT03997734
Tolerability, Safety and Pharmacokinetics of a Topical AB001 Patch in Healthy Subjects
A Phase 1 study testing AB001, oral capsule and positive comparative patch in people with Chronic Low Back Pain, run by Frontier Biotechnologies Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- AB001, oral capsule and positive comparative patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to 11 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- AB001, oral capsule, positive comparative patch, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB001Drug
Also called topical patch
single and repeated dosing
oral capsuleDrug
Also called active ingredient
single dose
positive comparative patchDrug
Also called topical patch
single and repeated dosing
PlacebosDrug
Also called topical patch
single and repeated dosing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline through Day 26
Secondary outcomes (4)
Safety Assessments on Skin Reaction Evaluation
Topical Skin Reaction Score(0-2 is a better outcome):
0= no evidence of irritation
- minimal erythema, barely perceptible
- definite erythema, readily visible; minimal edema or minimal papular response
- erythema and papules
- definite edema
- erythema, edema and papules
- vesicular eruption
- strong reaction spreading beyond application site
Measured: From baseline through Day 26
pharmacokinetic parameters of AB001(Cmax)
Peak Plasma Concentration (Cmax)
Measured: Day 1 and Day 26
pharmacokinetic parameters of AB001 (AUC)
Area under the plasma concentration versus time curve (AUC)
Measured: Day 1 and Day 26
bioavailability of AB001
To determine the bioavailability of AB001
Measured: Day 1 and Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start24 Jun 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frontier clinical team, Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997734
- Sponsor's protocol ID
- ABS-102
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03997734
- Acronym / sponsor ID
- ABS-102
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A-AB001 | Experimental | Drug: AB001, Drug: oral capsuleApply 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. |
| Treatment B-AB001 | Experimental | Drug: AB001Apply 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. |
| Treatment C | Active comparator | Drug: positive comparative patchApply 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. |
| Treatment A-Placebo | Placebo comparator | Drug: PlacebosApply 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. |
| Treatment B-Placebo | Placebo comparator | Drug: PlacebosApply 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB001Also: topical patchsingle and repeated dosing | Drug | Treatment A-AB001, Treatment B-AB001 |
| oral capsuleAlso: active ingredientsingle dose | Drug | Treatment A-AB001 |
| positive comparative patchAlso: topical patchsingle and repeated dosing | Drug | Treatment C |
| PlacebosAlso: topical patchsingle and repeated dosing | Drug | Treatment A-Placebo, Treatment B-Placebo |
Primary outcome
Number of subjects with any adverse events (AEs)
Time frame: From baseline through Day 26
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.
Number of subjects any serious adverse events (SAEs)
Time frame: From baseline through Day 26
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.
4 secondary outcomes
Safety Assessments on Skin Reaction Evaluation
Time frame: From baseline through Day 26
pharmacokinetic parameters of AB001(Cmax)
Time frame: Day 1 and Day 26
pharmacokinetic parameters of AB001 (AUC)
Time frame: Day 1 and Day 26
bioavailability of AB001
Time frame: Day 1 and Day 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frontier clinical team study director
Frontier Biotechnologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB001, oral capsule and positive comparative patch in people with Chronic Low Back Pain, run by Frontier Biotechnologies Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with any adverse events (AEs) (time frame: From baseline through Day 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.