protocolSection identificationModule nctId: NCT06298032, orgStudyIdInfo id: 000414, briefTitle: A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-11-12, completionDateStruct date: 2024-11-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Ferring Pharmaceuticals, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Inflammatory Gastrointestinal Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Olamkicept Part A, interventions name: Olamkicept Part B, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of treatment-emergent adverse events, including type, intensity, and causality, primaryOutcomes measure: Change in vital signs from baseline to Day 36 after a single dose infusion, primaryOutcomes measure: Change in vital signs from baseline to Day 64 after multiple dose infusions, primaryOutcomes measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion, primaryOutcomes measure: Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions, primaryOutcomes measure: Change in haematology from baseline to Day 36 after a single dose infusion, primaryOutcomes measure: Change in haematology from baseline to Day 64 after multiple dose infusions, primaryOutcomes measure: Change in clinical chemistry from baseline to Day 36 after a single dose infusion, primaryOutcomes measure: Change in clinical chemistry from baseline to Day 64 after multiple dose infusions, primaryOutcomes measure: Change in haemostasis parameters from baseline to Day 36 after a single dose infusion, primaryOutcomes measure: Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions, primaryOutcomes measure: Change in urinalysis parameters from baseline to Day 36 after a single dose infusion, primaryOutcomes measure: Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions, secondaryOutcomes measure: Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf), secondaryOutcomes measure: Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast), secondaryOutcomes measure: Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi), secondaryOutcomes measure: Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax), secondaryOutcomes measure: Single-dose PK of FE 999301: Time of maximum observed concentration (tmax), secondaryOutcomes measure: Single-dose PK of FE 999301: Terminal half-life (t1/2), secondaryOutcomes measure: Single-dose PK of FE 999301: Mean residence time (MRT), secondaryOutcomes measure: Single-dose PK of FE 999301: Total clearance (CL), secondaryOutcomes measure: Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss), secondaryOutcomes 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), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Observed accumulation index (Rac), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Terminal half-life (t½), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Mean residence time (MRT), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Total clearance (CL), secondaryOutcomes measure: Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss), secondaryOutcomes measure: Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ferring Investigational Site, status: RECRUITING, city: Berlin, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False