Trials / Completed
CompletedNCT02947854
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
An Open-label, Phase I/Proof of Principle, Dose Escalation Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation (PCI) of Antigen/Adjuvant in Healthy Male/Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- PCI Biotech AS · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fimaporfin (Photosensitizer) | |
| BIOLOGICAL | Hiltonol (Poly-ICLC) | |
| BIOLOGICAL | HPV E7 (Human Papilloma Virus E7) peptides | |
| BIOLOGICAL | KLH (Keyhole Limpet Hemocyanin) |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-03-26
- Completion
- 2018-03-26
- First posted
- 2016-10-28
- Last updated
- 2019-08-28
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02947854. Inclusion in this directory is not an endorsement.