A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection

Study Overview
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Brief Summary
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The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.

Official Title
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Relative Bioavailability of 40 mg/0.4 mL of BI 695501 Compared to 40 mg/0.8 mL of BI 695501 Formulation Following Single Subcutaneous Administration in Healthy Male and Female Subjects (a Double Blind, Randomised, Single-dose, Parallel-arm Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 695501 - higher concentration
* Drug: BI 695501 - lower concentration


Participation Criteria
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Eligibility Criteria
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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, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Age of 18 to 55 years (inclusive). Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive). Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Participants of reproductive potential (childbearing potential1) must be willing and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year from at least 30 days before administration of the trial medication until 30 days after trial completion. Exclusion Criteria: Previous exposure to adalimumab or proposed adalimumab biosimilar drugs. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) that deviates from normal and judged as clinically relevant by the investigator. Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or 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. Positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C (Hep C) at screening. History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex). Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial. Further exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solution for injection in prefilled syringe with higher concentration (Test)<br> | Drug: BI 695501 - higher concentration<br>* BI 695501 - higher concentration<br>|
| Experimental: Solution for injection in prefilled syringe with lower concentration (Reference)<br> | Drug: BI 695501 - lower concentration<br>* BI 695501 - lower concentration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 1344 hours after dose administration (AUC0-1344) |  | up to 57 days | 
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) |  | up to 57 days | 
| Maximum measured concentration of the analyte in plasma (Cmax) |  | up to 57 days |