Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses, it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
To assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men
Placebo to assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men
Ferring Investigational Site
Sumida-Ku, Tokyo, Japan
Number treatment-emergent adverse events
Number of treatment-emergent adverse events, including type, intensity, and causality
Time frame: From baseline up to 36 days after a single dose infusion
Blood pressure
Change from baseline in vital signs comprising systolic and diastolic blood pressure
Time frame: From baseline up to 36 days after a single dose infusion
Pulse
Change from baseline in vital signs comprising pulse
Time frame: From baseline up to 36 days after a single dose infusion
Body temperature
Change from baseline in vital signs comprising body temperature
Time frame: From baseline up to 36 days after a single dose infusion
Heart rate
Change from baseline in 12-lead electrocardiogram (ECG) assessing heart rate after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
PR interval
Change from baseline in 12-lead electrocardiogram ECG assessing the PR interval after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
RR interval
Change from baseline in 12-lead ECG assessing the RR interval after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
QRS duration
Change from baseline in 12-lead ECG assessing QRS duration after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
QT interval
Change from baseline in 12-lead ECG assessing QT interval after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
QTc interval
Change from baseline in 12-lead electrocardiogram (ECG) assessing QTc interval after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
QRS axis
Change from baseline in 12-lead ECG assessing QRS axis after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Change in haematology
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes) from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Clinical chemistry
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotranferase (ALT), albumin, alkaline phosphatase, aspartate aminotranferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltranferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Haemostasis
Blood and urine samples to assess change from baseline in haemostasis after a single IV dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Protein urinalysis parameter
Number of participants with clinically significant abnormal findings in protein urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Glucose urinalysis parameter
Number of participants with clinically significant abnormal findings in glucose urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Bilirubin urinalysis parameter
Number of participants with clinically significant abnormal findings in bilirubin urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
pH urinalysis parameter
Number of participants with clinically significant abnormal findings in pH urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Nitrate urinalysis parameter
Number of participants with clinically significant abnormal findings in nitrate urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Ketone urinalysis parameter
Number of participants with clinically significant abnormal findings in ketone urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Urobilinogen urinalysis parameter
Number of participants with clinically significant abnormal findings in urobilinogen urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Blood urinalysis parameter
Number of participants with clinically significant abnormal findings in blood urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Leukocyte urinalysis parameter
Number of participants with clinically significant abnormal findings in leukocyte urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Specific gravity urinalysis parameter
Number of participants with clinically significant abnormal findings in specific gravity urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Time frame: From baseline up to 36 days after a single dose infusion
Area under the Curve to Infinity (AUCinf)
Single-dose Pharmacokinetics of FE 999301 evaluating the AUCinf after single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Area Under the Curve last concentration (AUClast)
Single-dose Pharmacokinetics of FE 999301 evaluating AUClast after single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Concentration at the end of infusion (Ceoi)
Single-dose Pharmacokinetics of FE 999301 assessing Ceoi after single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Maximum concentration (Cmax)
Single-dose Pharmacokinetics of FE 999301 evaluating maximum concentration in the body Cmax after a single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Time to reach maximum concentration (tmax)
Single-dose Pharmacokinetics of FE 999301 evaluating time to reach the maximum concentration in the body after a single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Elimination half-life (t1/2)
Single-dose Pharmacokinetics of FE 999301 evaluating the amount of time required for the drug concentration to be reduced to exactly half of its initial concentration in the blood after single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Mean residence time (MRT)
Single-dose Pharmacokinetics of FE 999301 assessing the average time the drug stays in the body after single IV dose infusion in healthy Japanese men.
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Time frame: From baseline up to 36 days after a single dose infusion
Clearance (CL)
Single-dose Pharmacokinetics of FE 999301 evaluating the rate at which the drug is removed from the body after single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion
Volume of Distribution at steady state (Vss)
Single-dose Pharmacokinetics of FE 999301 assessing the volume of distribution at a steady state after single IV dose infusion in healthy Japanese men.
Time frame: From baseline up to 36 days after a single dose infusion