Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Fimaporfin (Photosensitizer); Biological: Hiltonol (Poly-ICLC); Biological: HPV E7 (Human Papilloma Virus E7) peptides; Biological: KLH (Keyhole Limpet Hemocyanin)

• Registration Number: NCT02947854
• Lead Sponsor: PCI Biotech AS

Brief Summary

Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance the effects of other drugs in a site-specific, light-directed manner and is used to re-localise endocytosed molecules from endosomes to cytosol. This research study is evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens for safety and induction of immune responses.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photosensitizer and adjuvant	Fimaporfin (Photosensitizer)	Run-in cohort for selection of fimaporfin starting dose in the main study. Single intradermal dosing of fimaporfin and adjuvant (Hiltonol \[poly-ICLC\]) followed by light application.
Photosensitizer and adjuvant	Hiltonol (Poly-ICLC)	Run-in cohort for selection of fimaporfin starting dose in the main study. Single intradermal dosing of fimaporfin and adjuvant (Hiltonol \[poly-ICLC\]) followed by light application.
Photosensitizer, adjuvant and antigens	Fimaporfin (Photosensitizer)	Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
Photosensitizer, adjuvant and antigens	Hiltonol (Poly-ICLC)	Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
Photosensitizer, adjuvant and antigens	HPV E7 (Human Papilloma Virus E7) peptides	Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
Photosensitizer, adjuvant and antigens	KLH (Keyhole Limpet Hemocyanin)	Main part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
Assessments of time between ID dosing and light	Fimaporfin (Photosensitizer)	Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
Assessments of time between ID dosing and light	Hiltonol (Poly-ICLC)	Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
Assessments of time between ID dosing and light	HPV E7 (Human Papilloma Virus E7) peptides	Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
Assessments of time between ID dosing and light	KLH (Keyhole Limpet Hemocyanin)	Optional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.

Primary Outcome Measures

Name	Time	Method
Pain as measured by Visual Analogue Scale (VAS)	Up to 1 year	Tolerability
Incidence and grading of local skin reactions as by CTCAE v. 4.03	Up to 1 year	Local Tolerability (pain, erythema, oedema, induration and ulceration)
Incidence of Treatment Emergent Adverse Events	Up to 1 year	Safety
Incidence of abnormal and clinical significant measures	Up to 1 year	Clinical Laboratory, ECG, Vital Signs and Physical Examinations

Secondary Outcome Measures

Name	Time	Method
Induction of Immune Response	Up to 1 year	Blood samples will be collected prior, during and after treatment for assessment of Antibody Production and T-cell Responses (change from baseline)

Trial Locations

Locations (1)

Covance Clinical Research Unit Limited; 🇬🇧 Leeds, United Kingdom