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CompletedNCT03239223Updated Jul 10, 2019

Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

A Phase 1 interventional study of ABI-1968 in HSIL, HSIL of Cervix and High-Grade Squamous Intraepithelial Lesions, sponsored by Antiva Biosciences. Completed at 9 sites in 2 countries. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-07-10.

Sponsored by Antiva Biosciences · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2018, 7 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
Female
01

Study summary

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

02

Conditions studied

  • HSIL
  • HSIL of Cervix
  • High-Grade Squamous Intraepithelial Lesions
  • High-grade Cervical Intraepithelial Neoplasia
  • Human Papilloma Virus
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • Cervical Neoplasm
  • Cervical Dysplasia
  • CIN
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 16 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Antiva Biosciences is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Dose 1 - Multiple Ascending Dose (MAD)

    ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

    Drug: ABI-1968

  • Experimental
    Dose 2 - Multiple Ascending Dose (MAD)

    ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

    Drug: ABI-1968

Interventions

  • DrugABI-1968

    Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL

    Number of participants with Adverse Events related to treatment to determine MTD

    Time frame: 85 Days

Secondary outcomes

  1. Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.

    Plasma concentrations of ABI-1968 over time to determine systemic exposure

    Time frame: 85 Days

  2. 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

    Time frame: 85 Days

07

Study locations

9 sites
  • Research Center
    Los Angeles, California 90036, United States
  • Research Center
    Lake Worth, Florida 33461, United States
  • Research Center
    Idaho Falls, Idaho 83404, United States
  • Research Center
    Chapel Hill, North Carolina 27517, United States
  • Research Center
    Winston-Salem, North Carolina 27101, United States
  • Research Center
    Norfolk, Virginia 84304, United States
  • Research Center
    Camperdown, New South Wales 2050, Australia
  • Research Center
    Darlinghurst, New South Wales 2010, Australia
  • Research Center
    South Brisbane, Queensland 4101, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03239223
Lead sponsor
Antiva Biosciences
Responsible party
Sponsor
First posted
Aug 3, 2017
Start date
Jan 1, 2018
Primary completion
Oct 30, 2018
Completion
Oct 30, 2018
Last update
Jul 10, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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