Clinical trial NCT06515834: Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroenterology
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number treatment-emergent adverse events
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Blood pressure
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Pulse
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Body temperature
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Heart rate
timeFrame: From baseline up to 36 days after a single dose infusion
measure: PR interval
timeFrame: From baseline up to 36 days after a single dose infusion
measure: RR interval
timeFrame: From baseline up to 36 days after a single dose infusion
measure: QRS duration
timeFrame: From baseline up to 36 days after a single dose infusion
measure: QT interval
timeFrame: From baseline up to 36 days after a single dose infusion
measure: QTc interval
timeFrame: From baseline up to 36 days after a single dose infusion
measure: QRS axis
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Change in haematology
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Clinical chemistry
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Haemostasis
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Protein urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Glucose urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Bilirubin urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: pH urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Nitrate urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Ketone urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Urobilinogen urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Blood urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Leukocyte urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Specific gravity urinalysis parameter
timeFrame: From baseline up to 36 days after a single dose infusion
Secondary outcomes:
measure: Area under the Curve to Infinity (AUCinf)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Area Under the Curve last concentration (AUClast)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Concentration at the end of infusion (Ceoi)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Maximum concentration (Cmax)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Time to reach maximum concentration (tmax)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Elimination half-life (t1/2)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Mean residence time (MRT)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Clearance (CL)
timeFrame: From baseline up to 36 days after a single dose infusion
measure: Volume of Distribution at steady state (Vss)
timeFrame: From baseline up to 36 days after a single dose infusion
Other outcomes:
Locations:
city: Sumida-Ku
country: Japan
facility: Ferring Investigational Site
state: Tokyo
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: