Safety and Immune Response to FMPV-1

This is an interventional treatment trial for Colorectal Cancer focused on measuring FMPV-1, Cancer-specific vaccine, Neoantigen, GM-CSF adjuvant Read More

Inclusion Criteria:

1. Healthy males
2. Aged 18 to 55 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
4. Must provide written informed consent
5. Must agree to adhere to the contraception requirements: male subjects who are sexually active with a partner of childbearing potential must use a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days (one cycle of spermatogenesis) after last vaccine administration.

Exclusion Criteria:

1. Subjects who have received any investigational medicinal product in a clinical research study within the 90 days prior to Day 1 or within less than 5 elimination half-lives prior to Day 1, whichever is longer
2. Subjects who are, or are immediate family members of, a study site or sponsor employee
3. Subjects who have previously been administered investigational medicinal product in this study.
4. Evidence of current SARS-CoV-2 infection
5. History of any drug or alcohol abuse in the past 2 years
6. Regular alcohol consumption defined as >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
7. A confirmed positive alcohol breath test at screening or admission
8. Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
10. Subjects with pregnant or lactating partners
11. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
12. Confirmed positive drugs of abuse test result
13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
14. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
15. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
16. Presence or history of a clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
17. Subjects currently receiving any agent with a known effect on the immune system within 90 days before first investigational medicinal product administration
18. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
19. Subjects who are taking, or have taken, any prescribed or over-the-counter medications, herbal remedies or antihistamines (other than vitamin supplements and/or up to 4 g of paracetamol per day) in the 7 days before investigational medicinal product administration
20. Subjects who have had a vaccine (including COVID-19 vaccine) within 28 days before first dose
21. Subjects with tattoos or scars on the arms which may interfere with injection site assessments, as determined by the investigator or delegate at screening

22. Subjects with any other illnesses or medical conditions such as, but not limited to:

    • Any infection that requires systemic treatment (any grade)
    • Cardiac failure (any grade)
    • Systemic and gastrointestinal inflammatory conditions
    • Bone marrow dysplasia
    • History of auto-immune disease
    • History of adverse reactions to any vaccines
    • History of adverse reactions to GM-CSF
23. Subjects with any other malignancies within the last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
24. Subjects planning to receive a yellow fever or other live (attenuated) vaccine during the course of study
25. Subject has a first degree relative with a haematological malignancy
26. Failure to satisfy the investigator of fitness to participate for any other reason