> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-in-healthy-people-to-test-how-2-different-c7697d9b-0ba2-47ac-b525-d97b457dceb5 > Record changed: 2026-10-13 # 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 NCT05203289 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) Participants 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) Start date 2022-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Dates **Completion date** 2022-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **First posted** 2022-01-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Registry last updated** 2024-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Primary completion date** 2022-08-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Start date** 2022-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Size and sites **Actual participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Identifiers **Registry ID** NCT05203289 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **ClinicalTrials.gov ID** NCT05203289 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Outcomes ### Primary outcomes 1. Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1344 Hours After Dose Administration (AUC0-1344) Timeframe: BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration. Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 to 1344 hours after dose administration (AUC0-1344). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight. 2. Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Timeframe: BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration. Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight. 3. Maximum Measured Concentration of BI 695501 in Plasma (Cmax) Timeframe: BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration. Maximum measured concentration of BI 695501 in plasma (Cmax). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Sites - Miami Research Associates, IncMiami, United States - QPS MOSpringfield, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## References - PubMed 38739422 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38739422/) Related publication - Related resource (www.mystudywindow.com) Source: [www.mystudywindow.com](https://www.mystudywindow.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05203289) ## Related records ### Drugs (1) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Targets (1) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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