CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 162 enrolled
Drug / intervention
BI695501 Prefilled syringe +1 moredrug
Likely dose
BI 695501 single dose subcutaneously via prefilled syringe or autoinjector (specific dose not stated)AI-extracted
Key inclusion· 4
  • ✓Age 18-65 years (inclusive)
  • ✓BMI >17.5 to <35.0 kg/m2
  • ✓Healthy status confirmed by complete medical history, physical exam, vital signs, 12-lead ECG, and clinical lab tests
  • ✓Adequate contraception from start of trial until 6 months after dose (females)
Key exclusion· 8
  • ✕Previous exposure to adalimumab or proposed adalimumab biosimilar drugs
  • ✕Any immunological or auto-immune disorders (e.g., Rheumatoid arthritis, lupus erythematosus, scleroderma)
  • ✕History of tuberculosis or positive Interferon-gamma release assay (IGRA)
  • ✕Positive result for HIV, HBV, or Hepatitis C at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02899338
NCT02899338Phase 1Completed
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Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector

Boehringer Ingelheim·interventional·Posted Sep 14, 2016·Updated Oct 11, 2018

In Brief

A Phase 1 clinical trial evaluating BI695501 Prefilled syringe and BI695501Autoinjector for Healthy. Completed, enrolled 162 participants across 2 sites in 2 countries.

Detailed Summary

To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after single injection using either auto injector or prefilled syringe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium, Netherlands
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 14, 2016
Enrollment StartSep 21, 2016
Primary CompletionFeb 9, 2017
Study CompletionFeb 23, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.8 years ago

Interventions

BI695501 Prefilled syringedrug

BI695501Autoinjectordrug