Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

NCT02852824 | Completed Phase 1 Results

• 2 other identifiers: 1368.22016-001235-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Drug-related Adverse Events (AEs).

  Percentage of subjects with investigator defined drug-related adverse events (AEs).

  From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)

Secondary Outcomes (5)

• Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Pharmacokinetic samples were collected at 2 hours pre-dose and 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration.

• Maximum Measured Concentration of the BI 655130 in Plasma (Cmax)

  Up to 4200 hours. Individual time points are provided in detail in description.

• Maximum Measured Concentration of BI 655130 in Plasma After the Fourth Dose (Cmax,4)

  Up to 4200 hours. Individual time points are provided in detail in description.

• Area Under the Concentration-time Curve of the BI 655130 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)

  Up to 4200 hours. Individual time points are provided in detail in description.

• Area Under the Concentration Time Curve of BI 655130 in Plasma After the Fourth Dose (AUCτ,4)

  Up to 4200 hours. Individual time points are provided in detail in description.

Study Arms (2)

BI 655130 (spesolimab)

EXPERIMENTAL

Drug: BI 655130 (spesolimab)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 655130 (spesolimab) DRUG

BI 655130 (spesolimab)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
• Age of 18 to 50 years (incl.)
• BMI of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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 judged 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)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Publications (1)

• Joseph D, Thoma C, Haeufel T, Li X. Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies. Clin Pharmacokinet. 2022 Dec;61(12):1771-1787. doi: 10.1007/s40262-022-01176-5. Epub 2022 Dec 1.

  PMID: 36451029 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

spesolimab

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: August 10, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)