A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Spesolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06520514

1368-0151

2023-510448-20-00 (Registry Identifier)

U1111-1301-8808 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Reference group

Active Comparator group

Description:

Reference treatment using the standard administration mode

Treatment:

Drug: Spesolimab

Test 1 group

Experimental group

Description:

Treatment 1 using the test administration mode

Treatment:

Drug: Spesolimab

Test 2 group

Experimental group

Description:

Treatment 2 using the test administration mode

Treatment:

Drug: Spesolimab