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

NCT04390568 | Completed Phase 1 Results

• 1 other identifier: 1368-0043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.

  Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.

• Maximum Measured Concentration of the Spesolimap in Plasma (Cmax)

  Maximum measured concentration of the Spesolimap in plasma (Cmax) The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-8). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.

  Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.

Secondary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (AE)s

  Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.

• Number of Participants With Drug-related Adverse Events (AEs).

  Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.

Study Arms (5)

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

EXPERIMENTAL

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

Drug: Spesolimap

Spesolimap - 900 mg - IV

EXPERIMENTAL

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

Drug: Spesolimap

Spesolimap - 1200 mg - IV

EXPERIMENTAL

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

Drug: Spesolimap

Spesolimap - 300 mg - subcutaneous (SC)

EXPERIMENTAL

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.

Drug: Spesolimap

Spesolimap - 600 mg - SC

EXPERIMENTAL

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.

Drug: Spesolimap

Interventions

Spesolimap DRUG

Spesolimap

Also known as: BI 655130

Spesolimap (BI 655130) - 450 milligram (mg) - intravenous (IV); Spesolimap - 1200 mg - IV; Spesolimap - 300 mg - subcutaneous (SC); Spesolimap - 600 mg - SC; Spesolimap - 900 mg - IV

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location

Related Publications (1)

• Cao G, Yang H, Wang J, Ishida M, Thoma C, Haeufel T, Bossert S, Zhang J. Pharmacokinetics and Safety of Spesolimab in Healthy Chinese Subjects: An Open-Label, Phase I Study. Adv Ther. 2024 Sep;41(9):3557-3568. doi: 10.1007/s12325-024-02940-8. Epub 2024 Jul 22.

  PMID: 39039387 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

spesolimab

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheimv

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 15, 2020
• Study Start: May 21, 2020
• Primary Completion: April 7, 2021
• Study Completion: June 4, 2021
• Last Updated: August 7, 2023
• Results First Posted: August 7, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)