HSILPhase 1NCT03239223
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
A Phase 1 study testing ABI-1968 in people with HSIL and HSIL of Cervix, run by Antiva Biosciences at 9 sites in 2 countries.
Trial summary
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- HSIL, HSIL of Cervix, High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- ABI-1968
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Jan 2018to 30 Oct 2018
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women, 25 to 50 years old.
- Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
- Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
- Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
Who cannot join
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Research Center
Chapel Hill, North Carolina, 27517
Research Center
Idaho Falls, Idaho, 83404
Research Center
Lake Worth, Florida, 33461
Research Center
Los Angeles, California, 90036
Research Center
Norfolk, Virginia, 84304
Research Center
Winston-Salem, North Carolina, 27101
Australia3 sites
Research Center
Camperdown, New South Wales, 2050
Research Center
Darlinghurst, New South Wales, 2010
Research Center
South Brisbane, Queensland, 4101
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
- Conditions
- HSIL, HSIL of Cervix, High-Grade Squamous Intraepithelial Lesions, High-grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus, Cervical Cancer
- Being tested
- ABI-1968
- Medical subject headings
- Squamous Intraepithelial Lesions, Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-1968Drug
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 - Multiple Ascending Dose (MAD) | Experimental | ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: ABI-1968 |
| Dose 2 - Multiple Ascending Dose (MAD) | Experimental | ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 Receives: Drug: ABI-1968 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Number of participants with Adverse Events related to treatment to determine MTD
Measured: 85 Days
Secondary outcomes (2)
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
Plasma concentrations of ABI-1968 over time to determine systemic exposure
Measured: 85 Days
Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
Number of subjects with complete and or partial regression of cHSIL by Colposcopy and histopathology to determine change and impact over 4 weekly doses
Measured: 85 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jan 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSILStudies 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
- Sequential
- Model description
- Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antiva Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239223
- Sponsor's protocol ID
- ABI-1968-102
- Status last verified
- Jul 2019
- First submitted
- 1 Aug 2017
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
- ClinicalTrials.gov ID
- NCT03239223
- Acronym / sponsor ID
- ABI-1968-102
- Conditions
- HSIL, HSIL of Cervix, High-Grade Squamous Intraepithelial Lesions, High-grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus, Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Antiva BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 3 Aug 2017 (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.
This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Up to two ascending dose cohorts (8 subjects per cohort) may receive multiple doses in 2 ascending dose strengths of ABI-1968 Topical Cream. After completing the multiple ascending dose portion a Cohort Expansion group of 32 to 40 subjects will be initiated.
| Arm | Type | Receives |
|---|---|---|
| Dose 1 - Multiple Ascending Dose (MAD) | Experimental | Drug: ABI-1968ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 |
| Dose 2 - Multiple Ascending Dose (MAD) | Experimental | Drug: ABI-1968ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women, 25 to 50 years old.
- Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
- Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
- Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
Key exclusion criteria (5 listed)
- Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
- History of cancer, except basal cell or squamous cell carcinoma of the skin.
- History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.
- Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
- History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.
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 |
|---|---|---|
| ABI-1968Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts | Drug | Dose 1 - Multiple Ascending Dose (MAD), Dose 2 - Multiple Ascending Dose (MAD) |
Primary outcome
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Time frame: 85 Days
Number of participants with Adverse Events related to treatment to determine MTD
2 secondary outcomes
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
Time frame: 85 Days
Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
Time frame: 85 Days
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 10 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-1968 in people with HSIL and HSIL of Cervix, run by Antiva Biosciences at 9 sites in 2 countries.
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 5 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. 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. 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?
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL (time frame: 85 Days). 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 10 Jul 2019.