N/A
Conditions
Interventions
Investigational Medicinal Products
Cohorts 1 to 3 will receive a single dose
Cohorts 4 to 8 will receive three doses
an initial loading dose on Day 1 and
two maintenance doses of no more than a nominal 50% of the loading dose,
administered on Day 29 and Day 57
Non-Investigational Medicinal Products
The following Non-Investigational Medicinal Products (NIMPs) will be
administered to volunteers in Cohorts 4 to 8 of the study:
Tetanus Toxoid: 0.5 mL on day
Immucothel®/Alhydrogel® 2% (European Pharmacopoeia: EP): 0.1 mg/0.9 mg in 0.5
mL on day 64.
Pharmacokinetics
Safety and Tolerability
Sponsors
Kymab Limited
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following criteria for entry into the study. 1. Volunteer to participate in the clinical trial and provide signed informed consent. 2. Cohorts 1 to 8: Male, aged 18 to 45 years. 3. Subjects with a female spouse/partner of childbearing potential must agree to use effective birth control starting at screening and continuing throughout the clinical study period and for a period of up to 6 months after study completion. 4. Cohorts 4 to 8: previous immunisation with tetanus toxoid (TT) but not within 6 months prior to the screening visit as reported by the volunteer. 5. Cohorts 4 to 8: anti-TT immunoglobulin G (IgG) response > 0.1 IU/mL and * 50 IU/mL at screening.
Exclusion criteria
Exclusion criteria: 1. Experiencing a clinically significant, chronic or acute infection requiring treatment at screening or prior to first IMP administration. 2. A body weight of * 60.0 kg or * 120.0 kg. 3. A body mass index (BMI) * 18.0 or * 30.0 kg. 4. History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system or metabolic/endocrine system or suffered from other disease that in the opinion of the PI (or medically qualified designee) may make participation unsafe for the subject or interfere with trial evaluations or otherwise considered clinically significant. 5. History of immunological abnormality (e.g., immune suppression, severe allergy or anaphylaxis) that in the opinion of the PI (or medically qualified designee) may make participation unsafe for the subject or interfere with trial evaluations or otherwise considered clinically significant. 6. History of malignancy, or known current malignancy. 7. Leukocyte absolute value 9.50 × 109/L, neutrophil absolute value four trials in the year preceding the first IMP administration. 9. Donated or lost more than 500 mL of blood or plasma within 3 months of screening. 10. Cohorts 1 to 8: prescription drug taken within 2 weeks of screening or likely to be taken during the trial. 11. Live immunisation within 3 months of screening or plans to receive such immunisation during the clinical trial or for a period of 6 months after the end of the trial. 12. Taking or likely to take over-the-counter (OTC) medication, including herbal medicines, that in the opinion of the PI (or medically qualified designee) may make participation unsafe for the subject or interfere with trial evaluations. 13. Hepatitis B surface antigen (HbsAg), Hepatitis C antibody (HCV-Ab), or Human Immunodeficiency Virus (HIV) positive. 14. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee) including a positive urine drug screen. 15. Current smoker and/or regular user of other nicotine-containing products (e.g., patches). 16. Average consumption of more than 14 units of alcohol/week. 17. Clinically significant abnormal screening values in clinical (electrocardiogram (ECG), vital signs, physical examination) and laboratory tests in the opinion of the PI (or medically qualified designee). 18. Cannot communicate adequately or cannot commit to full participation in all trial procedures. 19. For Cohorts 4 to 8: a. Confirmed previous exposure to immunocyanins, such as keyhole limpet haemocyanin (KLH); b. Known allergy to thiomersal or other components of Tetanus vaccine or Immucothel®; c. History of schistosomiasis. 20. Any observation that, in the opinion of the PI (or medically qualified designee) makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of KY1005 will be evaluated by measurement/recording of: - Adverse events (AEs); - Vital signs; - Laboratory safety tests; - ECGs; - Changes in physical examination; - Changes in anti-viral antibody levels and viral deoxyribonucleic acid (DNA); - Changes in acute cytokine levels (selected cohorts). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Serum concentrations of KY1005; - Serum anti-KY1005 antibody titres; - Serum anti-Immucothel and anti-TT antibody titers; - Immunophenotyping (analysis of cell subsets) in whole blood and evaluation of OX40L and/or OX40 expression on specific cell subsets where evaluable; - A blood sample taken before the first dose of study drug will be processed and stored for possible future sequencing for single nucleotide polymorphisms and/or deletions/duplications; - Any excess serum samples after planned analyses are complete will be retained for future evaluation of target related PD markers. | — |
Countries
The Netherlands
Outcome results
None listed