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
- 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.
- 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
- 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)
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2022-08-29
- First posted
- 2022-01-24
- Registry last updated
- 2024-03-15
- Primary completion date
- 2022-08-29
- Start date
- 2022-02-18
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Boehringer Ingelheim
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05203289
- ClinicalTrials.gov ID
- NCT05203289
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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.
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.
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.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Miami Research Associates, IncMiami, United States
- QPS MOSpringfield, United States
- PubMed 38739422Related publication
- Related resource (www.mystudywindow.com)