Clinical Trial: Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Phase 1 Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment When Applied Twice Daily for 28 Days in Male and Female Patients With Basal Cell Carcinoma

Brief Summary: This is a Phase 1, open-label, single-arm, multicenter study to assess the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment in subjects with BCC.

Detailed Summary: The purpose of the trial was to determine the safety and tolerability of BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days in male and female patients with BCC; and to determine the steady-state pharmacokinetics (PK) of the active pharmaceutical ingredient (total sheep Immunoglobulin G [IgG]) when BSCT (anti-nf-P2X7) 10% Ointment is applied twice daily to BCC lesions. This was an open-label, single-arm, multicenter Phase 1 study that enrolled 21 BCC patients.
Sponsor: Biosceptre

Current Primary Outcome:

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 8 weeks ]
    Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
  • Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA. [ Time Frame: 28 days ]
    To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.
  • Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay. [ Time Frame: 8 weeks ]
    The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).


Original Primary Outcome:

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 8 weeks ]
    Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
  • Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA. [ Time Frame: 8 weeks ]
    During the course of the study, subjects will have blood samples drawn to determine the serum concentration of total sheep IgG for the PK analysis (ng/ml)
  • Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay. [ Time Frame: 8 weeks ]
    During the course of the study, subjects will have blood samples drawn to determine the antibody response to the active pharmaceutical ingredient (anti-sheep IgG antibody titre) expressed as titre dilution ratio.
  • Efficacy - Reduction in the area of the lesion. [ Time Frame: 8 weeks ]
    The lesion will be measured weekly (mm2)
  • Efficacy - Reduction in number of tumour cells in the lesion. [ Time Frame: 8 weeks ]
    The number of tumour cells counted in a preliminary shave biopsy and compared with the end of study excision biopsy expressed as a percentage of total number o

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Biosceptre

    Dates:
    Date Received: October 21, 2015
    Date Started: May 2013
    Date Completion:
    Last Updated: March 15, 2016
    Last Verified: March 2016