Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

Sponsor
Boehringer Ingelheim
Study ID
NCT01505491
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • adalimumab — DRUG
    40mg adalimumab single s.c. injection
  • BI695501 — DRUG
    BI 695501 single s.c injection
  • adalimumab — DRUG
    40mg adalimumab single s.c. injection

Study Details

This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.

Key Dates

Start date
Dec 1, 2011
Status verified
Oct 2018
Primary completion
Jul 1, 2012
Completion
Jul 1, 2012

Study Design

Enrollment
193 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BI 695501
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
  • Active Comparator: adalimumab - US
    Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
  • Active Comparator: adalimumab - EU
    Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab

Primary Outcome Measure

Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration ]

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