Clinical trial NCT06520514: A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
Official title: Safety, Tolerability, and Relative Bioavailability of a Single Dose of Spesolimab Via Two Subcutaneous Modes of Delivery in Healthy Subjects (Mono-centric, Randomised, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects.


Eligibility criteria: Inclusion Criteria :

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 50 years (inclusive).
* Body mass index (BMI) of 18.5 to 30.0 kg/m\^2 (inclusive).
* Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Women of childbearing potential (WOCBP) must meet any of the following criteria for a highly effective contraception starting from at least 30 days before the administration of trial medication until 16 weeks after the injection/infusion of trial medication:

  * Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal),
  * Use of progestogen-only hormonal contraception that inhibits ovulation (oral, injectable or implantable),
  * Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS),
  * Bilateral tubal occlusion/ ligation,
  * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm in ejaculate) and provided that partner is the sole sexual partner of the woman of childbearing potential trial participant,
  * Complete abstinence (refraining from heterosexual intercourse) is considered a highly effective method of contraception only if it is in line with the preferred and usual lifestyle of the trial participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to trial investigational medicinal product, and withdrawal (coitus interruptus) are not acceptable.

Exclusion Criteria :

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
* History of relevant orthostatic hypotension, fainting spells, or blackouts.
* Participants with relevant chronic infections as determined by the investigator, including active or latent tuberculosis, Human Immunodeficiency Virus (HIV) or viral hepatitis. The corresponding laboratory tests will be performed during screening. In case of a positive hepatitis C antibody test, a positive reflex testing for Hepatitis C RNA (Ribonucleic Acid) PCR (polymerase chain reaction) is considered positive. For hepatitis B, exclusion criterion is met with either a positive Hepatitis B surface antigen or a positive Hepatitis B virus (HBV) DNA (Deoxyribonucleic Acid) PCR (HBV DNA PCR is done in case of positive Hepatitis core antibody and negative Hepatitis B surface antigen.).

Further exclusion criteria apply.

Primary outcomes:
measure: Occurrence of any treatment-emergent adverse event
timeFrame: Up to day 120
Secondary outcomes:
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: Up to day 120
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: Up to day 120
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: Up to day 120
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
References: