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
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2018
CompletedAugust 28, 2019
August 1, 2019
1.6 years
October 12, 2016
August 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of Treatment Emergent Adverse Events
Safety
Up to 1 year
Incidence of abnormal and clinical significant measures
Clinical Laboratory, ECG, Vital Signs and Physical Examinations
Up to 1 year
Pain as measured by Visual Analogue Scale (VAS)
Tolerability
Up to 1 year
Incidence and grading of local skin reactions as by CTCAE v. 4.03
Local Tolerability (pain, erythema, oedema, induration and ulceration)
Up to 1 year
Secondary Outcomes (1)
Induction of Immune Response
Up to 1 year
Study Arms (3)
Photosensitizer and adjuvant
EXPERIMENTALRun-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
EXPERIMENTALMain 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
EXPERIMENTALOptional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects will be; 1.1. males or females 1.2. Caucasian 1.3. between 18 and 55 years of age, inclusive
- Subjects will have a 2.1. body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive 2.2. body weight between 50 and 100 kg, inclusive
- Subjects will be in good health, as determined by; 3.1. medical history, 3.2. physical examination, 3.3. vital signs assessment, 3.4. 12-lead electrocardiogram (ECG) 3.5. clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is acceptable)
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
You may not qualify if:
- Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception (ie, a condom with spermicidal foam/gel/film/cream/suppository) or to refrain from donating sperm from the time of the first dose until 3 months after the final dose administration.
- Male subjects whose partners of childbearing potential do not agree to use an additional acceptable method of contraception.
- Female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception from the time of screening until 3 months after the final dose administration.
- Subjects who have a negative result for the test for human leukocyte antigen (HLA)-A2 (Parts B and C only).
- Subjects who have donated; 4.1. blood in the 3 months prior to screening, 4.2. plasma in the 7 days prior to screening, 4.3. platelets in the 6 weeks prior to screening.
- Subjects who; 5.1. consume more than 28 units of alcohol per week if male 5.2. consume more than 21 units of alcohol per week if female 5.3. have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator Note: 1 unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine or 25 mL of spirits
- Subjects who smoke more than 10 cigarettes or use the equivalent in tobacco per day.
- Subjects who have used the following within 7 days of first dose (use of intermittent paracetamol ≤2 g/day is acceptable), unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety:
- any non-prescribed systemic or topical medication 7.2. any herbal remedy 7.3. any vitamin supplement 7.4. any mineral supplement
- Subjects who have received; 8.1. any prescribed systemic or topical medication (including steroids) within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- slow-release medicinal formulations considered to still be active within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received a vaccine within 3 months of first dose administration.
- Subjects who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at screening and prior to first dose that in the opinion of the Investigator increases the risk of participating in the study.
- Subjects who have; 11.1. a positive urine drugs of abuse screen (confirmed by repeat) at screening or first admission.
- a positive alcohol breath test (confirmed by repeat) at screening or first admission.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PCI Biotech ASlead
Study Sites (1)
Covance Clinical Research Unit Limited
Leeds, LS29LH, United Kingdom
Related Publications (1)
Otterhaug T, Janetzki S, Welters MJP, Hakerud M, Nedberg AG, Edwards VT, Boekestijn S, Loof NM, Selbo PK, Olivecrona H, van der Burg SH, Hogset A. Photochemical Internalization Enhanced Vaccination Is Safe, and Gives Promising Cellular Immune Responses to an HPV Peptide-Based Vaccine in a Phase I Clinical Study in Healthy Volunteers. Front Immunol. 2021 Jan 8;11:576756. doi: 10.3389/fimmu.2020.576756. eCollection 2020.
PMID: 33488576DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jim Bush, MBChB, PhD, MRCS, MFPM
Covance Clinical Research Unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 28, 2016
Study Start
September 1, 2016
Primary Completion
March 26, 2018
Study Completion
March 26, 2018
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share