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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenterology
• Intervention / Treatment: Drug: Placebo; Drug: FE 999301

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Sumida-Ku, Tokyo, Japan, 130-0004
      • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo to assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men
Active Comparator: FE 999301	Drug: FE 999301; To assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): November 28, 2024
• Study Completion (Actual): November 28, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 000435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No