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Monoclonal Antibodies

BI 695501 40 mg/0.4 mL (T) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
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)
Maximum Measured Concentration of BI 695501 in Plasma (Cmax)

Trial Design

2Treatment groups
Experimental Treatment
Group I: BI 695501 40 mg/0.8 mL (R)Experimental Treatment1 Intervention
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
Group II: BI 695501 40 mg/0.4 mL (T)Experimental Treatment1 Intervention
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 695501 - lower concentration
2022
Completed Phase 1
~200
BI 695501 - higher concentration
2022
Completed Phase 1
~200

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05203289.
~63 spots leftby Apr 2025
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