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

December 5, 2024 updated by: Ferring Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From baseline up to 36 days after a single dose infusion
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
From baseline up to 36 days after a single dose infusion
Pulse
Time Frame: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising pulse
From baseline up to 36 days after a single dose infusion
Body temperature
Time Frame: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising body temperature
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion
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.
From baseline up to 36 days after a single dose infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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