Status:
COMPLETED
Safety and Immune Response to FMPV-1
Lead Sponsor:
Hubro Therapeutics AS
Collaborating Sponsors:
Quotient Sciences
Conditions:
Colorectal Cancer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a single centre, open-label, non-randomized, Phase I study assessing safety and immune response of FMPV-1 in healthy male subjects.
Detailed Description
To date, there is no clinical experience with FMPV-1. This is the first clinical study with FMPV-1 in healthy volunteers to assess the safety and immunogenicity of FMPV-1 in man. The study population ...
Eligibility Criteria
Inclusion
- Healthy males
- Aged 18 to 55 years inclusive at the time of signing informed consent
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
- Must provide written informed consent
- 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
- 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
- Subjects who are, or are immediate family members of, a study site or sponsor employee
- Subjects who have previously been administered investigational medicinal product in this study.
- Evidence of current SARS-CoV-2 infection
- History of any drug or alcohol abuse in the past 2 years
- 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)
- A confirmed positive alcohol breath test at screening or admission
- 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
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
- Subjects with pregnant or lactating partners
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of a clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Subjects currently receiving any agent with a known effect on the immune system within 90 days before first investigational medicinal product administration
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- 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
- Subjects who have had a vaccine (including COVID-19 vaccine) within 28 days before first dose
- Subjects with tattoos or scars on the arms which may interfere with injection site assessments, as determined by the investigator or delegate at screening
- 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
- 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)
- Subjects planning to receive a yellow fever or other live (attenuated) vaccine during the course of study
- Subject has a first degree relative with a haematological malignancy
- Failure to satisfy the investigator of fitness to participate for any other reason
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05238558
Start Date
January 31 2022
End Date
June 30 2023
Last Update
September 21 2023
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS