Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis

NCT03575780 | Completed Phase 1 FDA Drug

• 1 other identifier: KX01-AK-007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Amount of KX2-391 Ointment in the blood stream

  The measurement of KX2-391 Ointment levels in the blood stream over time

  6 Days

Secondary Outcomes (3)

• Local Skin Reactions

  29 Days

• Adverse Events

  29 Days

• Abnormal Laboratory Assessments

  29 Days

Study Arms (1)

KX2-391 Ointment

EXPERIMENTAL

KX2-391 ointment 1% will be administered once daily over 5 consecutive days

Drug: KX2-391 Ointment 1%

Interventions

KX2-391 Ointment 1% DRUG

The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical Actinic Keratosis on the face or balding scalp.

KX2-391 Ointment

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥18 years old.
• Able to comprehend and are willing to sign an informed consent form (ICF).
• At least 5 clinically typical, visible, and discrete AKs on 25 cm2 of the face or balding scalp.
• Subjects who, in the judgment of the Investigator, are in good general health based on:
• Medical history
• Physical examination (PE) findings
• ECG, clinical chemistry, hematology, and urinalysis results.
• In the case of a female of childbearing potential, TKL will initiate two forms of birth control at Screening and that at least one had to be in place for 30 days prior (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
• Females of childbearing potential, must agree to continue to use two methods of birth control for 30 days following the last dose of study treatment;
• In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
• In the case of sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment;
• In the case of a female of non-childbearing potential, has had a hysterectomy or is postmenopausal (at least 2 years with no menses prior to enrollment);
• All subjects must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment;
• Willing to avoid direct sun or ultraviolet (UV) light exposure to the face or scalp.

You may not qualify if:

• Clinically atypical and/or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and/or cutaneous horn.
• Location of the treatment area:
• Within 5 cm of an incompletely healed wound
• Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
• Been previously treated with KX2-391 ointment.
• Has QTcF \>450 ms for males and 470 ms for females or other relevant pathological changes in the ECG, in the opinion of the Investigation, at Screening.
• Anticipated need for in-patient hospitalization or in-patient surgery during the study.
• Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within 2 cm of the treatment area, within 8 weeks prior to the Screening visit.
• Use of the following therapies and/or medications within 2 weeks prior to the Screening visit:
• Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 2 cm of the selected treatment area
• Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within 2 cm of the selected treatment area
• Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical steroids within 2 cm of the selected treatment area; artificial tanners within 5 cm of the selected treatment area.
• Use of the following therapies and/or medications within 4 weeks prior to the Screening visit:
• Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers
• Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab)

Sponsors & Collaborators

• Athenex, Inc.: lead
• TKL Research, Inc.: collaborator

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Cutler, MD, FRCP

  Athenex, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will test KX2-391 Ointment 1%.

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 3, 2018
• Study Start: September 7, 2018
• Primary Completion: April 25, 2019
• Study Completion: October 10, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

US (1)