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OpenTrials
Completed

NCT Number: NCT06298032

A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons

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.

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Key information

Conditions

Inflammatory Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Ferring Investigational Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men ≥18 and ≤45 years of age at screening
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1

Exclusion criteria

  • History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Treatment and study plan

Olamkicept Part A

Drug

Intravenous infusion. Single dose.

Part A consists of 3 different doses

  • 1200 mg
  • 1800 mg
  • 2400 mg

Other names: FE 999301

Olamkicept Part B

Drug

Intravenous infusion. Multiple doses.

Part B consists of 3 different doses.

  • 1200 mg
  • 1800 mg
  • 2400 mg

Other names: FE 999301

Placebo

Drug

Intravenous infusion

Primary outcomes

  1. Number of treatment-emergent adverse events, including type, intensity, and causality

    Time frame: End of trial (up to 64 days)

  2. Change in vital signs from baseline to Day 36 after a single dose infusion

    Time frame: From baseline up to and including Day 36 after a single dose infusion

    Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 36 after a single dose infusion (part A of the study).

  3. Change in vital signs from baseline to Day 64 after multiple dose infusions

    Time frame: From baseline up to and including Day 64 after multiple dose infusions

    Number of participants with clinically significant abnormal findings in vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  4. Change in 12-lead electrocardiogram (ECG) from baseline to Day 36 after a single dose infusion

    Time frame: From baseline up to and including Day 36 after a single dose infusion

    Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  5. Change in 12-lead electrocardiogram (ECG) from baseline to Day 64 after multiple dose infusions

    Time frame: From baseline up to and including Day 64 after multiple dose infusions

    Number of participants with clinically significant abnormal findings in ECG (heart rate, PR interval, RR, QRS duration, QT interval, QTc interval, QRS axis), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  6. Change in haematology from baseline to Day 36 after a single dose infusion

    Time frame: From baseline to Day 36 after a single dose infusion

    Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (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 (part A of the study)

  7. Change in haematology from baseline to Day 64 after multiple dose infusions

    Time frame: From baseline to Day 64 after multiple dose infusions

    Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCH), mean corpuscular haemoglobin concentration (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 64 after multiple dose infusions (part B of the study)

  8. Change in clinical chemistry from baseline to Day 36 after a single dose infusion

    Time frame: From baseline to Day 36 after a single dose infusion

    Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, 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 (part A of the study)

  9. Change in clinical chemistry from baseline to Day 64 after multiple dose infusions

    Time frame: From baseline up to and including Day 64 after multiple dose infusions

    Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltransferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  10. Change in haemostasis parameters from baseline to Day 36 after a single dose infusion

    Time frame: From baseline up to and including Day 36 after a single dose infusion

    Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  11. Change in haemostasis parameters from baseline to Day 64 after multiple dose infusions

    Time frame: From baseline up to and including Day 64 after multiple dose infusions

    Number of participants with clinically significant abnormal findings in haemostasis parameters (activated partial thromboplastin time, prothrombin time) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

  12. Change in urinalysis parameters from baseline to Day 36 after a single dose infusion

    Time frame: From baseline to Day 36 after a single dose infusion

    Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 36 after a single dose infusion (part A of the study)

  13. Change in urinalysis parameters from baseline to Day 64 after multiple dose infusions

    Time frame: From baseline up to and including Day 64 after multiple dose infusions

    Number of participants with clinically significant abnormal findings in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, specific gravity) from baseline up to and including Day 64 after multiple dose infusions (part B of the study)

Secondary outcomes

  1. Single-dose PK of FE 999301: Area under the concentration-time curve from dosing to infinity (AUCinf)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  2. Single-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  3. Single-dose PK of FE 999301: Observed plasma concentration at end of infusion (AUCeoi)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  4. Single-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  5. Single-dose PK of FE 999301: Time of maximum observed concentration (tmax)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  6. Single-dose PK of FE 999301: Terminal half-life (t1/2)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  7. Single-dose PK of FE 999301: Mean residence time (MRT)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  8. Single-dose PK of FE 999301: Total clearance (CL)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  9. Single-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)

    Time frame: From baseline up to and including Day 36 after a single dose infusion

  10. Multiple-dose PK of FE 999301: Area under concentration-time curve from dosing up to time τ, where τ is the dosing interval (AUCτ)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  11. Multiple-dose PK of FE 999301: Area under the concentration-time curve to last measurable concentration (AUClast)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  12. Multiple-dose PK of FE 999301: Observed accumulation index (Rac)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  13. Multiple-dose PK of FE 999301: Observed plasma concentration at end of infusion (Ceio)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  14. Multiple-dose PK of FE 999301: Baseline adjusted maximum observed concentration; also referred to as maximum exposure (Cmax)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  15. Multiple-dose PK of FE 999301: Time of maximum observed concentration (tmax)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  16. Multiple-dose PK of FE 999301: Terminal half-life (t½)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  17. Multiple-dose PK of FE 999301: Mean residence time (MRT)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  18. Multiple-dose PK of FE 999301: Total clearance (CL)

    Time frame: From baseline up to and including Day 64 after a multiple dose infusions

  19. Multiple-dose PK of FE 999301: Apparent volume of distribution at steady-state (Vss)

    Time frame: Day 64

  20. Presence of anti-FE 999301 antibodies on Days 1, 15, and 57 after multiple dose infusions

    Time frame: On Days 1, 15, and 57 after multiple dose infusions

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Ascending Single and Multiple Doses in Healthy Subjects

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.