A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Spesolimap

Study type: Interventional

Funder types: Industry

Identifiers

NCT04390568

1368-0043

Details and patient eligibility

About

The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects (at least three subjects for each gender within each dose group) 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), respiratory rate (RR), body temperature), 12-lead ECG, and clinical laboratory tests.

• Chinese ethnicity, according to the following criteria: Ethnic Chinese, born in China and have 4 ethnic grandparents who were all born in China

• Age of 18 to 45 years (inclusive)

• Body weight ≥50 kg for male and ≥45 kg for female with body mass index (BMI) range ≥19 and < 26 kg/m2 at visit 1

• Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation

• Female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 16 weeks after trial completion [c03320877-06]:

  • Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information
  • A vasectomised sexual partner (vasectomy at least one year prior to enrolment)
  • Surgically sterilised (including hysterectomy)
  • Postmenopausal, defined as at least one year of spontaneous amenorrhoea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 mg/L is confirmatory)

Exclusion criteria

• Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to treatment or planned within 12 months after screening, e.g. hip replacement
• Any finding in the medical examination (including BP, PR, RR, Body temperature or 12-lead ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm
• 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
• Chronic or relevant acute infections including active and latent tuberculosis, human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON tuberculosis (TB) test will be performed at screening Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

Spesolimap (BI 655130) - 450 milligram (mg) - intravenous (IV)

Experimental group

Description:

A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.

Treatment:

Drug: Spesolimap

Spesolimap - 900 mg - IV

Experimental group

Description:

A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.

Treatment:

Drug: Spesolimap

Spesolimap - 1200 mg - IV

Experimental group

Description:

A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.

Treatment:

Drug: Spesolimap

Spesolimap - 300 mg - subcutaneous (SC)

Experimental group

Description:

A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.

Treatment:

Drug: Spesolimap

Spesolimap - 600 mg - SC

Experimental group

Description:

A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.

Treatment:

Drug: Spesolimap