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Completed

NCT Number: NCT06515834

Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese 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, 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.

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Key information

Conditions

Gastroenterology

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Ferring Investigational Site

Sumida-Ku, Tokyo, 130-0004, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

FE 999301

Drug

To assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men

Placebo

Drug

Placebo to assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men

Primary outcomes

  1. Number treatment-emergent adverse events

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

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

  2. Blood pressure

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

    Change from baseline in vital signs comprising systolic and diastolic blood pressure

  3. Pulse

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

    Change from baseline in vital signs comprising pulse

  4. Body temperature

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

    Change from baseline in vital signs comprising body temperature

  5. Heart rate

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

    Change from baseline in 12-lead electrocardiogram (ECG) assessing heart rate after a single IV dose infusion.

  6. PR interval

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

    Change from baseline in 12-lead electrocardiogram ECG assessing the PR interval after a single IV dose infusion.

  7. RR interval

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

    Change from baseline in 12-lead ECG assessing the RR interval after a single IV dose infusion.

  8. QRS duration

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

    Change from baseline in 12-lead ECG assessing QRS duration after a single IV dose infusion.

  9. QT interval

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

    Change from baseline in 12-lead ECG assessing QT interval after a single IV dose infusion.

  10. QTc interval

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

    Change from baseline in 12-lead electrocardiogram (ECG) assessing QTc interval after a single IV dose infusion.

  11. QRS axis

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

    Change from baseline in 12-lead ECG assessing QRS axis after a single IV dose infusion.

  12. Change in haematology

    Time frame: From baseline up to 36 days 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 (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.

  13. Clinical chemistry

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

    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.

  14. Haemostasis

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

    Blood and urine samples to assess change from baseline in haemostasis after a single IV dose infusion.

  15. Protein urinalysis parameter

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

    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.

  16. Glucose urinalysis parameter

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

    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.

  17. Bilirubin urinalysis parameter

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

    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.

  18. pH urinalysis parameter

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

    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.

  19. Nitrate urinalysis parameter

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

    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.

  20. Ketone urinalysis parameter

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

    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.

  21. Urobilinogen urinalysis parameter

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

    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.

  22. Blood urinalysis parameter

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

    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.

  23. Leukocyte urinalysis parameter

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

    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.

  24. Specific gravity urinalysis parameter

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

    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.

Secondary outcomes

  1. Area under the Curve to Infinity (AUCinf)

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

    Single-dose Pharmacokinetics of FE 999301 evaluating the AUCinf after single IV dose infusion in healthy Japanese men.

  2. Area Under the Curve last concentration (AUClast)

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

    Single-dose Pharmacokinetics of FE 999301 evaluating AUClast after single IV dose infusion in healthy Japanese men.

  3. Concentration at the end of infusion (Ceoi)

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

    Single-dose Pharmacokinetics of FE 999301 assessing Ceoi after single IV dose infusion in healthy Japanese men.

  4. Maximum concentration (Cmax)

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

    Single-dose Pharmacokinetics of FE 999301 evaluating maximum concentration in the body Cmax after a single IV dose infusion in healthy Japanese men.

  5. Time to reach maximum concentration (tmax)

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

    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.

  6. Elimination half-life (t1/2)

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

    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.

  7. Mean residence time (MRT)

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

    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.

  8. Clearance (CL)

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

    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.

  9. Volume of Distribution at steady state (Vss)

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

    Single-dose Pharmacokinetics of FE 999301 assessing the volume of distribution at a steady state after single IV dose infusion in healthy Japanese men.

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 Single Ascending Doses in Healthy Japanese Men

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Dec 6, 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.

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