Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons
NCT Number: NCT06515834
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Gastroenterology
Interventions: DRUG: FE 999301|DRUG: Placebo
Sponsor: Ferring Pharmaceuticals
Sex: MALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2024-11-26
Locations: Ferring Investigational Site, Sumida-Ku, Tokyo, 130-0004, Japan

Summary:
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.

Primary Outcome Measures: Number treatment-emergent adverse events, Number of treatment-emergent adverse events, including type, intensity, and causality, 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, From baseline up to 36 days after a single dose infusion|Pulse, Change from baseline in vital signs comprising pulse, From baseline up to 36 days after a single dose infusion|Body temperature, Change from baseline in vital signs comprising body temperature, 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., From baseline up to 36 days after a single dose infusion
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., From baseline up to 36 days after a single dose infusion