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

NCT02947854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-08-28

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Fimaporfin (Photosensitizer)

BIOLOGICAL

Hiltonol (Poly-ICLC)

BIOLOGICAL

HPV E7 (Human Papilloma Virus E7) peptides

BIOLOGICAL

KLH (Keyhole Limpet Hemocyanin)

Sponsors & Collaborators

  • PCI Biotech AS

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MBChB, PhD, MRCS, MFPM · Covance Clinical Research Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-03-26
Completion
2018-03-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947854 on ClinicalTrials.gov