nctId: NCT06298032 id: 000414 briefTitle: A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons overallStatus: RECRUITING date: 2024-02-20 date: 2024-11-12 date: 2024-11-12 date: 2024-03-07 date: 2024-03-07 name: Ferring Pharmaceuticals class: INDUSTRY briefSummary: 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 (600 mg every 2nd week for 12 weeks) 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 (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases. conditions: Inflammatory Gastrointestinal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Olamkicept Part A name: Olamkicept Part B name: Placebo measure: Number of treatment-emergent adverse events, including type, intensity, and causality measure: Change in vital signs from baseline to Day 36 after a single dose infusion measure: Change in vital signs from baseline to Day 64 after multiple dose infusions measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions measure: Change in haematology from baseline to Day 36 after a single dose infusion measure: Change in haematology from baseline to Day 64 after multiple dose infusions measure: Change in clinical chemistry from baseline to Day 36 after a single dose infusion measure: Change in clinical chemistry from baseline to Day 64 after multiple dose infusions measure: Change in haemostasis parameters from baseline to Day 36 after a single dose infusion measure: Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions measure: Change in urinalysis parameters from baseline to Day 36 after a single dose infusion measure: Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions measure: Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf) measure: Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) measure: Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi) measure: Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) measure: Single-dose PK of FE 999301: Time of maximum observed concentration (tmax) measure: Single-dose PK of FE 999301: Terminal half-life (t1/2) measure: Single-dose PK of FE 999301: Mean residence time (MRT) measure: Single-dose PK of FE 999301: Total clearance (CL) measure: Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) measure: Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ) measure: Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast) measure: Multiple-dose PK of FE 999301: Observed accumulation index (Rac) measure: Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio) measure: Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax) measure: Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax) measure: Multiple-dose PK of FE 999301: Terminal half-life (t½) measure: Multiple-dose PK of FE 999301: Mean residence time (MRT) measure: Multiple-dose PK of FE 999301: Total clearance (CL) measure: Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss) measure: Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ferring Investigational Site status: RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 hasResults: False